MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRH

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: 200 cases (858 units) Lot/code info: a. BREAST BIOPSY PACK-LF, Item Number: DYNJ0160598B, Case UDI/GTIN: 40889942051930, Unit UDI/GTIN: 10889942051939, Lot Number: 22IDB852; b. BREAST BIOPSY PACK, Item Number: DYNJ45087C, Case UDI/GTIN: 40195327044764, Unit UDI/GTIN: 10195327044763, Lot Number: 22JBO180; c. LAPAROTOMY PACK, Item Number: DYNJ55654B, Case UDI/GTIN: 40193489956727, Unit UDI/GTIN: 10193489956726, Lot Number: 22JDA974; d. BREAST PACK, Item Number: DYNJ56546C, Case UDI/GTIN: 40195327231164, Unit UDI/GTIN: 10195327231163, Lot Number: 22JBE655; e. SOFT TISSUE PACK, Item Number: DYNJ68311, Case UDI/GTIN: 40193489821933, Unit UDI/GTIN: 10193489821932, Lot Number: 22JBL797,22GBV060; f. HEMORRHOID PACK, Item Number: DYNJ69404, Case UDI/GTIN: 40193489936620, Unit UDI/GTIN: 10193489936629, Lot Number: 22HBI624; g. RECTAL, Item Number: DYNJ901758G, Case UDI/GTIN: 40193489979696, Unit UDI/GTIN: 10193489979695, Lot Number: 22JBQ935; h. BREAST, Item Number: DYNJ905525C, Case UDI/GTIN: 40195327122943, Unit UDI/GTIN: 10195327122942, Lot Number: 22JMF862,22HMH312; i. BREAST, Item Number: DYNJ906000B, Case UDI/GTIN: 40195327092697, Unit UDI/GTIN: 10195327092696, Lot Number: 22IBR879;

UPC codes

40889942051930, 10889942051939, 40195327044764, 10195327044763, 40193489956727, 10193489956726, 40195327231164, 10195327231163, 40193489821933, 10193489821932, 40193489936620, 10193489936629, 40193489979696, 10193489979695, 40195327122943, 10195327122942, 40195327092697, 10195327092696

Source

Official record: FDA (Device enforcement) ↗

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