MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF

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: 237 cases (1,242 units) Lot/code info: a. MINOR/BREAST BIOPSY-LF, Item Number: DYNJS3035, Case UDI/GTIN: 40884389421926, Unit UDI/GTIN: 10884389421925, Lot Number: 22IBK248,22IBB171,22HBM446; b. BREAST BIOPSY-LF, Item Number: DYNJT1911D, Case UDI/GTIN: 40888277808967, Unit UDI/GTIN: 10888277808966, Lot Number: 22JBG862,22HBV267

UPC codes

40884389421926, 10884389421925, 40888277808967, 10888277808966

Source

Official record: FDA (Device enforcement) ↗

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