Recall Z-1096-2025 ยท GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Ethicon, LLC
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
| Date | Feb 4, 2025 (initiated Dec 20, 2024) |
| Status | Open, Classified |
| Reason | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection. |
| Root cause | Process control |
| Action | On 12/20/2024, Johnson & Johnson Med Tech mailed recall notices to Operating Room Supervisors, Materials Management Personnel, Chief of Surgery, and distributors who were asked to do the following: 1) Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2) Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Pl |
| Quantity | 15,948 |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE ETHICON, Inc., Dec 6, 2013 |