MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CD

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: 101,102 cases (227,538 units) Lot/code info: a. SPINAL, Item Number: CDS780198O, Case UDI/GTIN: 40193489754101, Unit UDI/GTIN: 10193489754100, Lot Number: 22JBP283; b. SPINE CDS, Item Number: CDS780228D, Case UDI/GTIN: 40193489538329, Unit UDI/GTIN: 10193489538328, Lot Number: 22JMG559; c. TOTAL ORTHO CDS, Item Number: CDS940243K, Case UDI/GTIN: 40193489883443, Unit UDI/GTIN: 10193489883442, Lot Number: 22JBY480; d. TOTAL KNEE CDS, Item Number: CDS941144V, Case UDI/GTIN: 40195327132393, Unit UDI/GTIN: 10195327132392, Lot Number: 22JMG178; e. CDS HIP-LF, Item Number: CDS941183Q, Case UDI/GTIN: 40193489443449, Unit UDI/GTIN: 10193489443448, Lot Number: 22KMA031,22JMG560; f. KNEE TOTAL PACK-LF, Item Number: CDS941184Q, Case UDI/GTIN: 40193489444828, Unit UDI/GTIN: 10193489444827, Lot Number: 22JMB030; g. EXTREMITY CDS, Item Number: CDS941195L, Case UDI/GTIN: 40195327078271, Unit UDI/GTIN: 10195327078270, Lot Number: 22JBE513,22JBE512; h. SHOULDER ARTHRO CDS, Item Number: CDS941199M, Case UDI/GTIN: 40195327078295, Unit UDI/GTIN: 10195327078294, Lot Number: 22JBE580,22JBE558; i. GLENNON EXTREMITY CDS, Item Number: CDS941243P, Case UDI/GTIN: 40889942726487, Unit UDI/GTIN: 10889942726486, Lot Number: 22IBT784; j. KNEE ARTHROSCOPY, Item Number: CDS941418N, Case UDI/GTIN: 40889942702177, Unit UDI/GTIN: 10889942702176, Lot Number: 22JBD801; k. TOTAL KNEE, Item Number: CDS941419O, Case UDI/GTIN: 40193489754309, Unit UDI/GTIN: 10193489754308, Lot Number: 22IBT927,22IBO387; l. TOTAL HIP REPLACEMENT, Item Number: CDS941420P, Case UDI

UPC codes

40193489754101, 10193489754100, 40193489538329, 10193489538328, 40193489883443, 10193489883442, 40195327132393, 10195327132392, 40193489443449, 10193489443448, 40193489444828, 10193489444827, 40195327078271, 10195327078270, 40195327078295, 10195327078294, 40889942726487, 10889942726486, 40889942702177, 10889942702176, 40193489754309, 10193489754308, 40193489754415, 10193489754414, 40195327026074, 10195327026073, 40195327026098, 10195327026097, 40889942500919, 10889942500918, 40889942500902, 10889942500901, 40193489485234, 10193489485233, 40193489233286, 10193489233285, 40193489962247, 10193489962246, 40193489929127, 10193489929126

Source

Official record: FDA (Device enforcement) ↗

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