Device product

Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN

Z-1083-2023

November 17, 2022

Class II

Product summary

Firm: MEDLINE INDUSTRIES, LP - Northfield
Event: Event 91386
Status: Ongoing
Classification: Class II
Quantity: 100 cases (156 units)
Official record key: device-enforcement:Z-1083-2023

Official wording

Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

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

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.