Recall Z-0756-2025 ยท GEN Forceps, General & Plastic Surgery
MEDLINE INDUSTRIES, LP - Northfield
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
| Date | Dec 23, 2024 (initiated Nov 12, 2024) |
| Status | Open, Classified |
| Reason | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| Root cause | Process control |
| Action | On November 25, 2024, the firm notified customers via letters titled IMMEDIATE ACTION REQUIRED. Customers were informed that specific items and lots of Pure Pouch Single-Sterile and Sterile Kits are being recalled due to weak seals. Affected product must be destroyed. The letter included instructions on actions to take to be issued a credit. Customers should immediately check their stock for affected product and quarantine all units. Affected lots should be destroyed. When the recalling firm has received your completed destruction form, your account will be issued a credit, if applicable. If |
| Quantity | 21,440 total |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.