Recall Z-2462-2018 ยท GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Ethicon, Inc.
PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
| Date | May 7, 2018 |
| Status | Terminated |
| Reason | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. |
| Root cause | Package design/selection |
| Action | On May 24, 2018, the firm distributed Urgent: Medical Device Recall letters to affected U.S. customers. Customers were instructed 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 tha |
| Quantity | 4968 |
| Distribution | Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE ETHICON, Inc., Dec 6, 2013 |