Recall Z-1881-2024 ยท LMF Agent, Absorbable Hemostatic, Collagen Based
Ethicon, Inc.
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
| Date | May 22, 2024 (initiated Apr 23, 2024) |
| Status | Open, Classified |
| Reason | Some applicator tips from these lots had open seals. |
| Root cause | Under Investigation by firm |
| Action | On April 19, 2024 Urgent Medical Device Recall (Removal) letters were distributed to distributors and customers. Actions to be taken by customer: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 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 |
| Quantity | 5,184 units |
| Distribution | US Nationwide distribution in the states of AR, CA, FL, GA, ID, IL, IN, KY, MA, MD, MN, MO, NC, NE, NJ, PA, TN, TX, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.