MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOP

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: 42,593 cases (117,470 units) Lot/code info: a. LAPAROTOMY CDS-LF, Item Number: CDS860091A, Case UDI/GTIN: 40884389018324, Unit UDI/GTIN: 10884389018323, Lot Number: 22KMA029,22IMI179,22IME690; b. LAPAROSCOPY CDS-LF, Item Number: CDS860235I, Case UDI/GTIN: 40193489485210, Unit UDI/GTIN: 10193489485219, Lot Number: 22JMB557; c. BASIC LAPAROSCOPY CDS, Item Number: CDS920080S, Case UDI/GTIN: 40195327209606, Unit UDI/GTIN: 10195327209605, Lot Number: 22JBO105; d. LAPAROSCOPY CDS-LF, Item Number: CDS920126AB, Case UDI/GTIN: 40193489203296, Unit UDI/GTIN: 10193489203295, Lot Number: 22JMD700; e. GENERAL LAPAROSCOPY PROCEDURE, Item Number: CDS930125V, Case UDI/GTIN: 40195327255504, Unit UDI/GTIN: 10195327255503, Lot Number: 22JBH334,22JBA038; f. LAP CHOLE CDS, Item Number: CDS930235K, Case UDI/GTIN: 40889942108160, Unit UDI/GTIN: 10889942108169, Lot Number: 22IMD079; g. COLO-RECTAL CDS-LF, Item Number: CDS941345K, Case UDI/GTIN: 40195327062867, Unit UDI/GTIN: 10195327062866, Lot Number: 22IBT398,22HBW953; h. MAJOR PROCEDURE-LF, Item Number: CDS980255U, Case UDI/GTIN: 40195327255306, Unit UDI/GTIN: 10195327255305, Lot Number: 22JBW968; i. HYPOSPADIUS CDS, Item Number: CDS980372K, Case UDI/GTIN: 40195327251445, Unit UDI/GTIN: 10195327251444, Lot Number: 22JBV275; j. LAPAROSCOPY-GENERAL, Item Number: CDS980746I, Case UDI/GTIN: 40889942428565, Unit UDI/GTIN: 10889942428564, Lot Number: 22JBR293,22JBB178,22JBB179; k. LAP CHOLE CDS, Item Number: CDS981016D, Case UDI/GTIN: 40193489976732, Unit UDI/GTIN: 10193489976731, Lot Number: 22

UPC codes

40884389018324, 10884389018323, 40193489485210, 10193489485219, 40195327209606, 10195327209605, 40193489203296, 10193489203295, 40195327255504, 10195327255503, 40889942108160, 10889942108169, 40195327062867, 10195327062866, 40195327255306, 10195327255305, 40195327251445, 10195327251444, 40889942428565, 10889942428564, 40193489976732, 10193489976731, 40193489995016, 10193489995015, 40889942913603, 10889942913602, 40195327144990, 10195327144999, 40889942620976, 10889942620975, 40193489928700, 10193489928709, 40195327212347, 10195327212346, 40193489861465, 10193489861464, 40193489321877, 10193489321876, 40193489362924, 10193489362923

Source

Official record: FDA (Device enforcement) ↗

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