MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST

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: 6,420 cases (15,009 units) Lot/code info: a. BREAST AUGMENTATION, Item Number: CDS982254L, Case UDI/GTIN: 40195327084791, Unit UDI/GTIN: 10195327084790, Lot Number: 22JBU069,22IBN271; b. BREAST REDUCTION CDS, Item Number: CDS982255I, Case UDI/GTIN: 40195327084807, Unit UDI/GTIN: 10195327084806, Lot Number: 22JBB306; c. CUH ABDOMINOPLASTY CDS, Item Number: CDS983176I, Case UDI/GTIN: 40193489767477, Unit UDI/GTIN: 10193489767476, Lot Number: 22JBJ560,22JBD705; d. ACH PLASTICS BREAST-LF, Item Number: CDS983639J, Case UDI/GTIN: 40195327228140, Unit UDI/GTIN: 10195327228149, Lot Number: 22IBF012,22IBF004; e. NE BREAST RECON CDS, Item Number: CDS983660G, Case UDI/GTIN: 40193489952675, Unit UDI/GTIN: 10193489952674, Lot Number: 22IBR079; f. PLASTIC SURGERY CDS, Item Number: CDS983880C, Case UDI/GTIN: 40193489435963, Unit UDI/GTIN: 10193489435962, Lot Number: 22JBT961; g. MINOR PLASTIC CDS, Item Number: CDS984174F, Case UDI/GTIN: 40195327084777, Unit UDI/GTIN: 10195327084776, Lot Number: 22JBM928,22JBM929; h. GROTH BREAST CDS, Item Number: CDS984202U, Case UDI/GTIN: 40195327146307, Unit UDI/GTIN: 10195327146306, Lot Number: 22JBA856,22IBC582,22IBD063; i. BREAST ABD, Item Number: CDS984267J, Case UDI/GTIN: 40193489288873, Unit UDI/GTIN: 10193489288872, Lot Number: 22IBF074; j. MINOR/U-BAR CDS-LF, Item Number: CDS984539J, Case UDI/GTIN: 40193489903189, Unit UDI/GTIN: 10193489903188, Lot Number: 22JDB904; k. PLASTIC BREAST CDS-LF, Item Number: CDS984851K, Case UDI/GTIN: 40195327195398, Unit UDI/GTIN: 10195327195397, Lot Number:

UPC codes

40195327084791, 10195327084790, 40195327084807, 10195327084806, 40193489767477, 10193489767476, 40195327228140, 10195327228149, 40193489952675, 10193489952674, 40193489435963, 10193489435962, 40195327084777, 10195327084776, 40195327146307, 10195327146306, 40193489288873, 10193489288872, 40193489903189, 10193489903188, 40195327195398, 10195327195397, 40195327071760, 10195327071769, 40195327175765, 10195327175764, 40193489511957, 10193489511956, 40193489919173, 10193489919172, 40193489259590, 10193489259599, 40195327024599, 10195327024598, 40888277256508, 10888277256507, 40888277785350, 10888277785359, 40195327106943, 10195327106942

Source

Official record: FDA (Device enforcement) ↗

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