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
Counter (beta, gamma) for clinical use - Product Code JJJ
Causa
The content of the second #023 barcode id label in the barcode id label binder is incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. if measurement protocols have been programmed for both id #023 and #024, the protocol associated with barcode id #024 is executed. if the error is undetected, the gamma counter may produce erroneous results.
Acción
Perkin Elmer sent an Urgent Medical Device Correction letter dated December 7, 2015 to affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to destroy all affected products in their possession. Customers were asked to complete the
enclosed Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com . Corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. For further information contact your local PerkinElmer representatives..
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
Counter (beta, gamma) for clinical use - Product Code JJJ
Causa
The content of the second #023 barcode id label in the barcode id label binder is incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. if measurement protocols have been programmed for both id #023 and #024, the protocol associated with barcode id #024 is executed. if the error is undetected, the gamma counter may produce erroneous results.
Acción
Perkin Elmer sent an Urgent Medical Device Correction letter dated December 7, 2015 to affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to destroy all affected products in their possession. Customers were asked to complete the
enclosed Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com . Corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. For further information contact your local PerkinElmer representatives..
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
Counter (beta, gamma) for clinical use - Product Code JJJ
Causa
The content of the second #023 barcode id label in the barcode id label binder is incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. if measurement protocols have been programmed for both id #023 and #024, the protocol associated with barcode id #024 is executed. if the error is undetected, the gamma counter may produce erroneous results.
Acción
Perkin Elmer sent an Urgent Medical Device Correction letter dated December 7, 2015 to affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to destroy all affected products in their possession. Customers were asked to complete the
enclosed Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com . Corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. For further information contact your local PerkinElmer representatives..
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
Counter (beta, gamma) for clinical use - Product Code JJJ
Causa
The content of the second #023 barcode id label in the barcode id label binder is incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. if measurement protocols have been programmed for both id #023 and #024, the protocol associated with barcode id #024 is executed. if the error is undetected, the gamma counter may produce erroneous results.
Acción
Perkin Elmer sent an Urgent Medical Device Correction letter dated December 7, 2015 to affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to destroy all affected products in their possession. Customers were asked to complete the
enclosed Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com . Corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. For further information contact your local PerkinElmer representatives..
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
Retractor, self-retaining - Product Code FFO
Causa
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Acción
On 12/17/2015 the firm sent Recall Notification Letters to their customers. The letter identified the product, problem, and actions to be taken by the customer.
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
Counter (beta, gamma) for clinical use - Product Code JJJ
Causa
The content of the second #023 barcode id label in the barcode id label binder is incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. if measurement protocols have been programmed for both id #023 and #024, the protocol associated with barcode id #024 is executed. if the error is undetected, the gamma counter may produce erroneous results.
Acción
Perkin Elmer sent an Urgent Medical Device Correction letter dated December 7, 2015 to affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to destroy all affected products in their possession. Customers were asked to complete the
enclosed Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com . Corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. For further information contact your local PerkinElmer representatives..
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.
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.
Incorrect version of instructions for use were shipped to two us customers.
Acción
RenovoRx notified customers by phone and by mail of this issue. This notification requests that the customers remove the affected product from their inventory and remove and replace the incorrect Instructions for Use with the correct Instructions for Use provided by RenovoRx.
The customers are requested to return the incorrect Instruction for Use to RenovoRx for disposition and are requested to complete a Recall Confirmation Form enclosed to document the completion of the requested Correction.
For further questions, please call (650) 284-4433.
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
Introducer, catheter - Product Code DYB
Causa
The guidewire introducer needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration.
there is a potential risk of a soft tissue infection to the patient if device is used after expiration date.
Acción
Stryker sent an Urgent Medical Device Recall Notification letter dated November 24, 2015, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
For questions regarding this recall, please contact Stryker Instruments:
Monday-Friday 8am-5pm (EST)
269-389-2921
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
Instruments, dental hand - Product Code DZN
Causa
Ultradent is recalling interguard 5.5mm econo refill, lot#s bc2gn and bc4l7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.
Acción
Ultradent Products sent an Urgent Medical Device Correction letter dated December 21, 2015 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard remaining inventory. Replacement product will be sent to each of the identified customers upon completion. For questions regarding the recall call 801-553-4366 or 801-553-4220.
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.
Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.
Acción
Zimmer sent an Urgent Medical Device Removal letter on December 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed:
I. Review this notification.
2. You will receive copies of notification sent directly to hospital risk managers and surgeons in your territory. As necessary, review and facilitate understanding of this notification by those entities.
3. Further identify hospital risk managers and/or surgeons in your territory who should also receive notification of this update, and supply the information to the entities you have identified.
4. If after reviewing this notification you have further questions or concerns, please call 330-364-0989 between the hours of 8 a.m. and 5 p.m. EST, Monday through Friday.
Letters to Rick Managers are similar and the actions requested by them are:
1. Reviewing this notification and forwarding to all people within your organization that may utilize this product.
2. Identifying and quarantining the affected product to prevent further distribution or use.
3. Completing the attached Response Form and returning it via e-mail to
CorporateQua1ity.PostMarket@zimmerbiomet.com. Returning affected product to:
Zimmer Surgical
Attn: QA!RA Dept. - Recall
Please include a copy of the Response Form with the shipment.
4. Upon receipt of affected product, Zimmer will credit your account for unused Zimmer Oscillating Flat Blade - TS ST Hub, 75mm x 19mm, xl.OO/l.27mm, lots 43054 and 45104 only. Please return a copy of the completed response form along with your returned product to ensure proper credit.
Important: Please distribute this notification to all personnel within your organization who need to be aware. If you have further distributed affected product(s), please provide the customer 's information on the Business Response Form to Zimmer.
Letters also included a FAQ sheet regarding the labeling error.
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 nebulizer mask malfunctions in that there is reduced or no aerosol output. the malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.
Acción
The firm, ConvaTec, sent each consignee affected by the recall an overnight express mail "Urgent Voluntary Recall Notice" and Response Form dated 12/7/2015. The notice described the product, problem and actions to be taken. The recall notice instructed the consignee to immediately stop distributing and quarantine all affected lots; perform a count of all recalled product currently in inventory; complete and return the enclosed Recall Response Form by email at convatec3657@stericyle.com or by fax at 1-888-603-8986, and return all affected product, (ONLY return the lots affected with this recall). If you want replacement product contact customer service by phone at 1-800-634-6003, extension 1103 or by email at respiratoryorders@convatec.com.
If you have any questions call 1-877-650-3492.
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.
Defibrillation electrodes may increase electrical impedance over time. if impedance becomes too high, the aed will fail the electrode self-test and it will not be rescue ready, the aed status indicator will be red and the aed will beep. this is normal behavior when the impedance limit is exceeded. the high impedance electrodes require replacement.
Acción
Cardiac Science sent an Urgent: Voluntary Medical Device Recall letter dated January 2016 starting on January 14, 2014. The letters were either addressed to Distributor or Customer. The letter described the problem and the product involved in the recall. Requested consignees to replace any electrodes from the lot 141125-02 and return them to Cardiac Science. Furthermore, it advised consignees to contact their customers or members of their facilities who need to be made aware by providing a copy of the notification letter and replacement electrodes if they were a distributor. For questions contact Cardiac Science Technical Support at 1-800-426-0337, option 1 in USA or +1-262-953-3500 OUS or via e-mail a9131cardiacscience.com. For questions regarding this recall call 800-426-0337.
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 that information printed on the quick reference magnet is incorrect; specifically, fahrenheit to celsius temperature conversions and the default warming cabinet temperature.
Acción
The firm, Steris, sent an "URGENT VOLUNTARY FIELD CORRECTION NOTICE" letter dated 12/14/2015 to its customers. The letter described the product, problem and actions to be taken. The firm included an updated quick reference magnet for each affected unit with the letter. The customers were instructed to replace your existing magnet with the enclosed magnet.
If you have questions regarding this matter, please contact Product Manager, at 440-392-7705 or STERIS Customer Service at 1-800-548-4873.
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
Saw, powered, and accessories - Product Code HAB
Causa
The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
Acción
Zimmer sent an Urgent Medical Device Correction letter dated November 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
1. Review this notification.
2. You will receive copies of notification sent directly to hospital risk managers and surgeons in your territory. As necessary, review and facilitate understanding of this notification by those entities.
3. Further identify hospital risk managers and/or surgeons in your territory who should also receive notification of this update, and supply the information to the entities you have identified.
4. If after reviewing this notification you have further questions or concerns, please call 330-364-0989 between the hours of 8 a.m. and 5 p.m. EST, Monday through Friday.
Zimmer instructed their direct customers that they will upgrade the device with the new electronic during their annual preventative maintenance activities. Until the new upgrade is installed, the firm instructed their customers to follow the Instructions for Use.
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.
For the syngo workflow slr system with software ver: vb10c: printouts may be printed in incorrect anatomical size when using syngo imaging xs filming application in conjunction with a printer not released for anatomical print usage. this may happen due to an invalid combination of printer and the syngo imaging xs printer configuration file.
Acción
11/17/2015, CSAN sent to customers with a list of suitable printers for the anatomical printing.
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
Passer - Product Code HWQ
Causa
There may be a separation
and an insufficient weld between the spring and washer. the weld between the spring and washer may fracture,
causing the mamba suture passer instruments jaw to not actuate properly.
6 complaints have been received in which 3 have been reported with a delay up to 10 minutes.
Acción
On 12/2/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors and hospital risk managers via courier with instructions to locate and return the affected products. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
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
Passer - Product Code HWQ
Causa
There may be a separation
and an insufficient weld between the spring and washer. the weld between the spring and washer may fracture,
causing the mamba suture passer instruments jaw to not actuate properly.
6 complaints have been received in which 3 have been reported with a delay up to 10 minutes.
Acción
On 12/2/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors and hospital risk managers via courier with instructions to locate and return the affected products. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
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
Screwdriver, surgical - Product Code LRZ
Causa
The flexible shaft of the instruments may break during orthopedic spinal surgery. there is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Acción
The firm, Aesculap Implant Systems, sent a "URGENT MEDICAL DEVICE RECALL" letter dated Nov. 23, 2015 to all consignees via certified letter with return receipt. Distributors and sales reps will be notified via e-mail with return receipt. The letter described the product, problem and actions to be taken. The consignees were instructed to review the product recall notification in its entirety and ensure all users your organization and other concerned persons are informed; determine your current inventory; do not destroy any affected product; immediately remove and return the affected instruments-these instruments may be located within Set ST0485; use the U joint screwdriver, ME014R in place of the SJ706R of which is already part of set ST0485; If you require Customer Service assistance please call: Customer Service: 866-229-3002 or Email: SetWorld_Orders.BBMUS_Service@aesculap.com., and complete and return the Product Removal Acknowledgement Form to Aesculap Quality Assurance Department via mail to: Aesculap Inc., 615 Lambert Pointe Drive, Hazelwood, MO 63042; fax to: 610-791-6882 or email to: val.strawn@aesculap.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0).
A replacement for the SJ607R will be sent to you when one becomes available (ME190R).
If you have any questions, contact via email: val.strawn@aesculap.com/Tel: 610-984-9414 or email: Gordon.young@aesculap.com/Tel: 610-984-9043.
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
Screwdriver, surgical - Product Code LRZ
Causa
The flexible shaft of the instruments may break during orthopedic spinal surgery. there is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Acción
The firm, Aesculap Implant Systems, sent a "URGENT MEDICAL DEVICE RECALL" letter dated Nov. 23, 2015 to all consignees via certified letter with return receipt. Distributors and sales reps will be notified via e-mail with return receipt. The letter described the product, problem and actions to be taken. The consignees were instructed to review the product recall notification in its entirety and ensure all users your organization and other concerned persons are informed; determine your current inventory; do not destroy any affected product; immediately remove and return the affected instruments-these instruments may be located within Set ST0485; use the U joint screwdriver, ME014R in place of the SJ706R of which is already part of set ST0485; If you require Customer Service assistance please call: Customer Service: 866-229-3002 or Email: SetWorld_Orders.BBMUS_Service@aesculap.com., and complete and return the Product Removal Acknowledgement Form to Aesculap Quality Assurance Department via mail to: Aesculap Inc., 615 Lambert Pointe Drive, Hazelwood, MO 63042; fax to: 610-791-6882 or email to: val.strawn@aesculap.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0).
A replacement for the SJ607R will be sent to you when one becomes available (ME190R).
If you have any questions, contact via email: val.strawn@aesculap.com/Tel: 610-984-9414 or email: Gordon.young@aesculap.com/Tel: 610-984-9043.
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.
Zimmer biomet is initiating a recall of the virage occipital eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.
Acción
Consignees were sent a Zimmer Biomet "Urgent Medical Device Recall" letter dated November 17, 2015. One letter was addressed to Risk Manager and Surgeons and a separate letter was sent to Distributors, Sales Representatives, and Distributor Operations Mangers. The letters described the problem and the product involved in the recall. The letter described the "Risk" and the responsibilities of consignees and requested consignees to quarantine the product. Risk Managers and Surgeons were requested to complete and return the Certificate of Acknowledgment form. Distributors, Sales Representatives, and Distributor Operations Mangers were requested to complete and return the Inventory Return certification Form.
For questions consignees can call the customer call center at 1-866-774-6368 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.
Notas adicionales en la data
Retractor, self-retaining - Product Code FFO
Causa
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Acción
On 12/17/2015 the firm sent Recall Notification Letters to their customers. The letter identified the product, problem, and actions to be taken by the customer.
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 public reason for the recall is that the product is being recalled out of an abundance of caution due to one or more consumer complaints, which have been independently investigated and remain unconfirmed. no causal connection between the complaints and the producta¿"s proper use as instructed have been determined.".
Acción
The firm has only sold the product to Walgreens. Walgreens has notified all of its distribution centers and stores. According to the firm: "Walgreens has issued a stop sale at the store level. Units removed from store shelves and in stock will be sent back to the Walgreens distribution center Valparaiso, Indiana. As units are received from all store locations they will be sent to Bigwall Enterprises."
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
Syringe, antistick - Product Code MEG
Causa
Potential improper bonding between the tube and luer for certain lots of surflo winged infusion set with filter and needle protection (surshield).
Acción
Terumo N.V. Europe notified their US Importer (Termumo Medical Corporation, Somerset, NJ) of the voluntary recall on 11/23/2015 via phone and email. Terumo Medical Corporation in turn notified their sole consignee on 11/24/2015 by email that included the manufacturers Recall Notification. The notification informed the customer of the reason for the recall; how to identify affected product; to immediately identify and quarantine any available stock; and complete and return the attached Reply Form.
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, balloon, dilation of cervical canal - Product Code PFJ
Causa
Stability data does not substantiate the labeled two-year shelf life of affected product.
Acción
Ethicon, Inc. sent "Urgent: Medical Device Recall (REMOVAL)" notifications and Business Reply Forms dated 12/3/2015 on same date via UPS Next Day Mail to its customers. The notification informed the customers of the issue with the product; how to identify affected product and action required. The customers were instructed to examine their inventory immediately to determine if they have affected product on hand and quarantine the affected product(s); remove the affected product and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed; if any affected product has been forwarded to another facility, contact that facility to arrange return; complete and return the enclosed Business Reply Form (BRF) confirming receipt of this notice within three (3) business days to Stericycle by fax at 1-866-792-5453 or by email at Ethicon7427@stericycle.com, return BRF even if you do not have affected product. Stericycle is handling returns.
If the customer requires any assistance with returning product or have any questions, they were instructed to contact the Customer Support Center at 1-877-ETHICON (1-877-384-4266).
Ethicon, Inc. issued an update to their 12/3/2015 letter in a notification dated 12/23/2015. The 12/23/2015 notification clarified the lots of the product subject to their recall previously communicated in their 12/3/2015 letter. There are three (3) lots of product subject to the recall that were inadvertently omitted from the original lot listing. The notification stated that "All THERMACHOICE¿ Catheter lots with an expiration date prior to December 10, 2017 are subject to this recall and are required to be returned. The lot number listing of all product subject to the recall is contained in Attachment 1. The expiration date and lot number can be determined by using the Product Identification Tool attached hereto at Attachment 2." The attachments included the updated pr