Recall Z-2406-2024 ยท LMG Agent, Absorbable Hemostatic, Non-Collagen Based
Ethicon Sarl, a Johnson & Johnson Company
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
| Date | Jul 17, 2024 (initiated Jun 11, 2024) |
| Status | Open, Classified |
| Reason | Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging. |
| Root cause | Process control |
| Action | On Jun 11, 2024, URGENT: MEDICAL DEVICE RECALL (REMOVAL) letters were sent to consignees. ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have the lot numbers from the product codes listed in Attachment 1 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 recall |
| Quantity | 450,793 units (65,950 US, 384,843 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of India and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.