MEDLINE INDUSTRIES, LP – Northfield Recall 95806
Description: SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
MEDLINE INDUSTRIES, LP – Northfield Recall 95806 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0722-2025 |
| Event ID | 95806 |
| Event Description | SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures. |
| Product Type | Devices |
| Distribution | US Nationwide. Canada. |
| Quantity | 40 kits |
| Recall Reason | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods |
| Device Classification | 20250101 |
| Device Code Info | UDI-DI: 10193489789935(each), 40193489789936(case); Lot Number: 20JBD814 |
| Center Classification Date | 20241220 |
| Recall Initiation Date | 20241106 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Initial Notification | Letter |
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