Retiro De Equipo (Recall) de VICRYL RAPIDE Suture

Recall

79086

Class 2

Z-0693-2018

2017-08-17

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161312

On august 17, 2017, ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of vicryl rapidetm (polyglactin 910) suture that were distributed to the field. during finished goods testing, a suture damage was identified on a lot of vicryl rapidetm suture. during the course of the subsequent investigation, the suture also failed knot tensile strength testing.

On August 31, 2017 a Medical Device recall letter (Reference 2210968-08.31.17-003-R) was issued requesting customers to do the following: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. If you have additional questions regarding this recall (removal) or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax: " Online: www.fda.gov/medwatch/report.htm " Regular Mail: Use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 " Fax: 1-800-FDA-0178