MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY

Hazard

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

Details from the source

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: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates. Quantity: 109 cases (316 units) Lot/code info: a. PELVISCOPY PACK, Item Number: DYNJ82555, Case UDI/GTIN: 40195327198252, Unit UDI/GTIN: 10195327198251, Lot Number: 22HBQ035; b. D-PELVISCOPY, Item Number: DYNJ900628I, Case UDI/GTIN: 40195327224142, Unit UDI/GTIN: 10195327224141, Lot Number: 22JDB340;

UPC codes

40195327198252, 10195327198251, 40195327224142, 10195327224141

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.