Z-1083-2023 Class II Ongoing
FDA device recall Z-1083-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Nov 17, 2022 and is designated Class II. Reason for recall: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. The recall status is ongoing. Affected quantity: 100 cases (156 units).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 15, 2023
- Initiation Date
- Nov 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 cases (156 units)
Product Description
Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
Reason for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1083-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026