MEDLINE INDUSTRIES, LP – Northfield Recall 95806
Description: KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
MEDLINE INDUSTRIES, LP – Northfield Recall 95806 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0725-2025 |
Event ID | 95806 |
Event Description | KIT,SPINE LH Convenience kit, SKU DYNJ906448A. |
Product Type | Devices |
Distribution | US Nationwide. Canada. |
Quantity | 160 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: 10193489408508(each), 40193489408509(case); Lot Number: 21EBG271 21CBS664 20LBO883 20WBE707 |
Center Classification Date | 20241220 |
Recall Initiation Date | 20241106 |
Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
Initial Notification | Letter |
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