U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Unit, x-ray, extraoral with timer - Product Code EHD
Causa
Firm received customer complaints where end users reported that nomad pro and pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack pcb.
Acción
The firm sent a "FIELD ACTION NOTICE" to all affected customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Impactor - Product Code HWA
Causa
Stryker orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the trident universal impactor/positioner.
Acción
Stryker sent an Urgent Medical Device Recall Notification dated August 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Actions Needed:
1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization.
2. Branches/Agencies: Return all affected products available at your location to
Stryker C/0 Stericycle
3. Hospitals/Branches: Complete and sign the enclosed Business Reply Form and fax a copy to 877-546-0444 or email to Stericycle strvkerortho6536@stericycle.com.
Our records indicate that you have received the above referenced instrument. It is our responsibility to ensure that customers who may have received this affected instrument also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Business Reply Form within 5 days.
We regret any inconvenience this action may cause you and if you have any questions, feel free to contact me at (201) 831-6693.
For further questions regarding this recall, please call (201) 831-5000.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm received multiple reports of xhibit telemetry system going offline or locking up. in addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single canadian hospital.
Acción
Spacelabs sent a letter dated August 25, 2016 to affected US consignees informing them of the going offline or locking up issue when Xhibit Central Station is used as part of an Xhibit Telemetry System. On September 1, 2016, a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record.
Spacelabs sent the second Urgent - Medical Device Correction letter, dated September 15, 2016, to affected US consignees informing them that they have received reports of certain short-duration asystole alarms generated by the Xhibit Telemetry Receiver (XTR) where there may be no audible or visual alarm. On September 22, 2016, a second letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record.
Spacelabs Healthcare will contact consignees to schedule a convenient time for Spacelabs to update the recalled Xhibit Telemetry System at no cost. Customers with Xhibit Telemetry Receivers will get all Xhibit Central Stations updated regardless if connected to an Xhibit Telemetry Receiver.
Consignees are directed to technical support for additional information or technical assistance:
Technical Support
Spacelabs Healthcare, Inc
35301 SE Center St.
Snoqualmie, WA 98065
1-800-522-7025 and select 2 for Technical Support
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, nuclear magnetic resonance imaging - Product Code LNH
Causa
Ge healthcare is conducting a recall dealing with an incorrect rf power monitor function involving signa creator and signa explorer which could result in higher than expected thermal dose to the patient and higher than expected localized heating. there have been no failures of this type reported, and no injuries reported as a result of this issue.
Acción
Consignees were sent on 8/31/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 67921 dated August 31, 2016. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, and Radiologists.
The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Plate, fixation, bone - Product Code HRS
Causa
Trimed is recalling the semi-tubular plates with 10 holes (smtp-10) because a non-locking screw passed through a hole in a smtp-10 plate being implanted.
Acción
The firm, TriMed, sent a "Medical Device Recall Notification" Letter dated 8/29/16 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and quarantine the product subject to this recall; notify your customers at once of this product recall; discontinue use; return product, and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form as soon as possible by Fax to: 1-661-254-8485 or email to: davidmedoff@trimedortho.com.
Customers with questions are instructed to contact Director of Operations at (800) 633-7221, davidmedoff@trimedortho.com, M-F, 9am-5pm, Pacific Standard.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Multiple customers reported seeing an increase in imprecision with some patients resulting in high % cvs with the immulite 2000/2000xpi cmv (igm) assay starting with reagent lots 259 and above.
Acción
The firm, Siemens, issued an "Urgent Medical Device Recall" Letter (IMC16-22.A.US, dated 8/30/2016) in the US and an "Urgent Field Safety Notice" (IMC16-22.A.OUS, dated August 2016) Outside the US (OUS) starting on 8/30/2016 The notices instructed customers to discontinue use of and discard the affected kit lots listed in the customer notice; review your inventory of the products to determine your laboratory's replacement needs; review the UMDR and or the UFSN with their Medical Director, In the US, the method of distribution is FedEx and Outside the US the distribution is determined at the country level; complete and return the Field Correction Effectiveness Check Form via Fax to: Customer Care Center at (312) 275-7795 within 30 days, and retain this letter with your laboratory records, and forward this letter to those who may have received this product.
If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Chest drainage kit - Product Code PAD
Causa
Outer packaging is not sterile.
Acción
Atrium Medical issued recall letter on 11/29/16 via two-day express mail delivery advising users: of the problem, updated instructions for use; the new Warning Label applied to the packaging; and requesting to post the warning label near all Atrium chest drain product inventory.
A Field Notification Reply Form acknowledging receipt of the Field Notification was requested to be completed and returned.
Questions contact Atrium/Maquet/Getinge chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Multiple customers reported seeing an increase in imprecision with some patients resulting in high % cvs with the immulite 2000/2000xpi cmv (igm) assay starting with reagent lots 259 and above.
Acción
The firm, Siemens, issued an "Urgent Medical Device Recall" Letter (IMC16-22.A.US, dated 8/30/2016) in the US and an "Urgent Field Safety Notice" (IMC16-22.A.OUS, dated August 2016) Outside the US (OUS) starting on 8/30/2016 The notices instructed customers to discontinue use of and discard the affected kit lots listed in the customer notice; review your inventory of the products to determine your laboratory's replacement needs; review the UMDR and or the UFSN with their Medical Director, In the US, the method of distribution is FedEx and Outside the US the distribution is determined at the country level; complete and return the Field Correction Effectiveness Check Form via Fax to: Customer Care Center at (312) 275-7795 within 30 days, and retain this letter with your laboratory records, and forward this letter to those who may have received this product.
If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Icu medical inc. has identified a potential risk of leaking with certain tego connector devices.
Acción
The firm, icumedical, sent an "URGENT: Medical Device Recall Notification" letter dated 8/24/16 to all their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to quarantine any affected devices; remove from use, return to ICU medical, Inc.; and complete and return the recall response form to ICU Medical via fax (801) 264-1755 or at recall@icumed.com (even if you do not have any affected product).
Customers with questions are instructed to contact ICU customer service Monday through Friday between 8:30AM and 4:00PM Pacific Time, (866) 829-9025 and select option 8 or email the following: customerservice@icumed.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Media, reproductive - Product Code MQL
Causa
Products contain international package insert and not
the correct usa package insert.
Acción
CooperSurgical sent an Advisory Notice dated August 25, 2016, to affected customers via UPS with confirmed delivery receipt.
The letter identified the affected product and detailed the necessary actions to be taken by customers who carried the affected lots in their inventory. The advisory notification asked customers to replace the previously inserted incorrect Instructions for use (IFU) with the correct IFU sent with the advisory notification.
For questions regarding this recall call 203-601-5200.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Media, reproductive - Product Code MQL
Causa
Products contain international package insert and not
the correct usa package insert.
Acción
CooperSurgical sent an Advisory Notice dated August 25, 2016, to affected customers via UPS with confirmed delivery receipt.
The letter identified the affected product and detailed the necessary actions to be taken by customers who carried the affected lots in their inventory. The advisory notification asked customers to replace the previously inserted incorrect Instructions for use (IFU) with the correct IFU sent with the advisory notification.
For questions regarding this recall call 203-601-5200.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
ConvaTec sent an Urgent Medical Device Correction letter to all affected consignees on November 7, 2014. The letter notified the consignees of what action they need to take if they experience a detached tubing.
You can continue to use your infusion sets by following the advice below.
1. When changing your infusion set, closely follow the instructions for use included in the product box. Check the tubing at the connect/disconnect location identified in the drawings above to make sure it is not loose.
2. As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.
3. If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure.
If you discover the tubing is detached:
1. Do not attempt to reattach the tubing. Replace the infusion set immediately.
2. Treat any high blood sugar based on guidelines provided by your healthcare professional.
3. Call your distributor's Helpline to report the issue. They will give you instructions on how to return the affected infusion set.
The letter included a reply card to be returned.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Stand, infusion - Product Code FOX
Causa
Casters on the ekos carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
Acción
The firm, EKOS, sent an "URGENT FIELD SAFETY ACTION" letter dated August 22, 2016 to its customers. The letters were sent to customers informing them of the field safety action, how to identify the affected carts at their facility and instructing customers locate the cart, quarantine it and do not use the cart for any procedures. A representative from EKOS Corporation will be contacting customers in the near future to arrange a date and time when the cart at a facility can be inspected and any affected caster(s) replaced. As the cart is inspected, it will be tagged to easily identify it and confirm it has been inspected and repaired as necessary.
Customers will be provided with a copy of the inspection/repair form for the cart they inspect. Please retain that form for records.
If customers have any questions, please contact EKOS Customer Service at 1-888-400-3567 or your local EKOS representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
ConvaTec sent an Urgent Medical Device Correction letter to all affected consignees on November 7, 2014. The letter notified the consignees of what action they need to take if they experience a detached tubing.
You can continue to use your infusion sets by following the advice below.
1. When changing your infusion set, closely follow the instructions for use included in the product box. Check the tubing at the connect/disconnect location identified in the drawings above to make sure it is not loose.
2. As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.
3. If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure.
If you discover the tubing is detached:
1. Do not attempt to reattach the tubing. Replace the infusion set immediately.
2. Treat any high blood sugar based on guidelines provided by your healthcare professional.
3. Call your distributor's Helpline to report the issue. They will give you instructions on how to return the affected infusion set.
The letter included a reply card to be returned.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
ConvaTec sent an Urgent Medical Device Correction letter to all affected consignees on November 7, 2014. The letter notified the consignees of what action they need to take if they experience a detached tubing.
You can continue to use your infusion sets by following the advice below.
1. When changing your infusion set, closely follow the instructions for use included in the product box. Check the tubing at the connect/disconnect location identified in the drawings above to make sure it is not loose.
2. As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.
3. If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure.
If you discover the tubing is detached:
1. Do not attempt to reattach the tubing. Replace the infusion set immediately.
2. Treat any high blood sugar based on guidelines provided by your healthcare professional.
3. Call your distributor's Helpline to report the issue. They will give you instructions on how to return the affected infusion set.
The letter included a reply card to be returned.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
ConvaTec sent an Urgent Medical Device Correction letter to all affected consignees on November 7, 2014. The letter notified the consignees of what action they need to take if they experience a detached tubing.
You can continue to use your infusion sets by following the advice below.
1. When changing your infusion set, closely follow the instructions for use included in the product box. Check the tubing at the connect/disconnect location identified in the drawings above to make sure it is not loose.
2. As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.
3. If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure.
If you discover the tubing is detached:
1. Do not attempt to reattach the tubing. Replace the infusion set immediately.
2. Treat any high blood sugar based on guidelines provided by your healthcare professional.
3. Call your distributor's Helpline to report the issue. They will give you instructions on how to return the affected infusion set.
The letter included a reply card to be returned.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Terumo cardiovascular systems (terumo cvs) has received complaints of the cdi system 500 monitor displaying the h/s disconnect at cuvette error message when the cdi h/s cuvette does not make a proper connection to the cdi h/s probe. in this situation, blood parameter values for hct, hgb, and so2 do not display.
Acción
Terumo (Planned Action) plans to execute the following steps as part of the correction activity:
Notify all customers of the potential that a cuvette may disengage from the circuit (probe) leading to a "disconnect" message on the monitor. This notification will be performed via a Customer Notification Letter.
For further questions, please call (410) 392-7277.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
ConvaTec sent an Urgent Medical Device Correction letter to all affected consignees on November 7, 2014. The letter notified the consignees of what action they need to take if they experience a detached tubing.
You can continue to use your infusion sets by following the advice below.
1. When changing your infusion set, closely follow the instructions for use included in the product box. Check the tubing at the connect/disconnect location identified in the drawings above to make sure it is not loose.
2. As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.
3. If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure.
If you discover the tubing is detached:
1. Do not attempt to reattach the tubing. Replace the infusion set immediately.
2. Treat any high blood sugar based on guidelines provided by your healthcare professional.
3. Call your distributor's Helpline to report the issue. They will give you instructions on how to return the affected infusion set.
The letter included a reply card to be returned.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter, embolectomy - Product Code DXE
Causa
Arrow is recalling due to incorrect labeling of products.
Acción
The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated July 07, 2016 via FedEx to its customers. The letter described the product, problems and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any products they may have on hand; return product, and complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com, even if you have no affected stock.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Resin, root canal filling - Product Code KIF
Causa
Sybronendo is recalling the sealapex xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11.
Acción
The firm, Kerr, sent an "Urgent: Medical Device Recall" letter dated 8/31/16 to its customers. The letter describes the product, problem and actions to be taken. The customer were instructed to contact SybronEndo Customer Care at (800) 537-7123 to receive a RMA number if they have any of the affected product; and to complete and email back the enclosed acknowledgement form to Sealapex.Response@kerrdental.com , even if they do not have any of the affected product.
If you have any questions, call 714-516-7802 or email to: mark.dzendzel@syndrondental.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
Causa
Three complaints describing trusystem tables unexpectedly descending approximately 20 centimeters.
Acción
Trumpf Medical sent an Urgent Field Safety Notice dated July 8, 2015, to all affected consignees. The letter indicated that the tables should not be used until an authorized service engineer has exchanged the spindles of the affected operating tables. The letter included an acknowledgement form which is to be returned. The letter also requested a sub-recall if the product had been further distributed. For questions regarding this recall call 843-329-0543.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
Causa
Three complaints describing trusystem tables unexpectedly descending approximately 20 centimeters.
Acción
Trumpf Medical sent an Urgent Field Safety Notice dated July 8, 2015, to all affected consignees. The letter indicated that the tables should not be used until an authorized service engineer has exchanged the spindles of the affected operating tables. The letter included an acknowledgement form which is to be returned. The letter also requested a sub-recall if the product had been further distributed. For questions regarding this recall call 843-329-0543.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
Acción
Merge sent Urgent Medical Device Recall dated January 28, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions Merge Customer Service at (877) 741-5369 or support@merge.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Product code l- 7b-g1 was inadvertently released off of hold status and the affected products were distributed.
Acción
On April 26, 2016 DePuy Synthes sent a letter informing their customers of the recall.
ACTION REQUIRED
Our records show that your facility has received one or more of product(s) subject to the recall (correction). The Anspach
Effort, Inc. asks that you:
1) There is no requirement for retaining your inventory of Gl Dissection Tools.
2) To ensure Gl Cutting Tool & Attachment compatibility, please reference Table 1 to review which Attachments are
compatible. The Cutting TooVAttachment combination noted with a check mark in Table I will function as intended.
The Cutting Tool/Attachment combinations noted with an "X" in Table 1 will not secure effectively and should not be
used.
3) Review, complete, sign and return the attached reply form confirming your receipt of this letter by fax or email details
provided on the form. Returning the form promptly will prevent you from receiving repeat notices.
1. Share this letter with others in your facility that needs to be made aware of this recall (correction).
2. If you distribute any of the product(s) subject to the recall (correction) to other services or facilities, please forward
this letter as appropriate immediately.
3. Keep a copy of this notice with the product(s) subject to the recall (correction).
If you have any questions regarding this correction, please contact the Complaint Handling Unit Manager at 561-494-3673
or contact your Anspach Sales Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm discovered on march 4, 2016 that several product codes were inadvertently left off of hold 1503.
Acción
On April 26, 2016 DePuy Synthes sent a letter informing their customers of the recall.
ACTION REQUIRED
Our records show that your facility has received one or more of product(s) subject to the recall (correction). The Anspach
Effort, Inc. asks that you:
1) There is no requirement for retaining your inventory of Gl Dissection Tools.
2) To ensure Gl Cutting Tool & Attachment compatibility, please reference Table 1 to review which Attachments are
compatible. The Cutting TooVAttachment combination noted with a check mark in Table I will function as intended.
The Cutting Tool/Attachment combinations noted with an "X" in Table 1 will not secure effectively and should not be
used.
3) Review, complete, sign and return the attached reply form confirming your receipt of this letter by fax or email details
provided on the form. Returning the form promptly will prevent you from receiving repeat notices.
1. Share this letter with others in your facility that needs to be made aware of this recall (correction).
2. If you distribute any of the product(s) subject to the recall (correction) to other services or facilities, please forward
this letter as appropriate immediately.
3. Keep a copy of this notice with the product(s) subject to the recall (correction).
If you have any questions regarding this correction, please contact the Complaint Handling Unit Manager at 561-494-3673
or contact your Anspach Sales Representative.