MEDLINE INDUSTRIES, LP – Northfield Recall 91387
Description: Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
MEDLINE INDUSTRIES, LP – Northfield Recall 91387 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1032-2023 |
Event ID | 91387 |
Event Description | Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case |
Product Type | Devices |
Distribution | US Nationwide distribution in the states of AR, MD, WA, WI. |
Quantity | 160 cases (480 units) |
Recall Reason | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. |
Device Classification | 20230208 |
Device Code Info | Item Number: DYNJ900416M, UDI/GTIN Case: 40195327031672, UDI/GTIN Each: 10195327031671, Lot Number: 22IBQ980 |
Center Classification Date | 20230127 |
Recall Initiation Date | 20221117 |
Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
Initial Notification | Letter |
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