MEDLINE INDUSTRIES, LP – Northfield Recall 91386
Description: Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
MEDLINE INDUSTRIES, LP – Northfield Recall 91386 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1083-2023 |
| Event ID | 91386 |
| Event Description | Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates. |
| Quantity | 100 cases (156 units) |
| Recall Reason | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| Device Classification | 20230215 |
| Device Code Info | a. MAJOR CDS-LF, Item Number: CDS983861D, Case UDI/GTIN: 40193489524353, Unit UDI/GTIN: 10193489524352, Lot Number: 22JDB004; b. BURN PACK-LF, Item Number: DYNJ0781678S, Case UDI/GTIN: 40193489226349, Unit UDI/GTIN: 10193489226348, Lot Number: 22IMC056; c. BURN PACK, Item Number: DYNJ82534, Case UDI/GTIN: 40195327198504, Unit UDI/GTIN: 10195327198503, Lot Number: 22HBI219; d. SMALL BURN, Item Number: DYNJ901793L, Case UDI/GTIN: 40193489955065, Unit UDI/GTIN: 10193489955064, Lot Number: 22KBB743,22IBH124 |
| Center Classification Date | 20230206 |
| Recall Initiation Date | 20221117 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
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