MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f.

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: 8,064 cases (12,425 units) Lot/code info: a. GYN-URO LAPSCP CDS-LF, Item Number: CDS981583U, Case UDI/GTIN: 40195327209767, Unit UDI/GTIN: 10195327209766, Lot Number: 22JBE255; b. ROBOTIC CDS, Item Number: CDS981882W, Case UDI/GTIN: 40195327144983, Unit UDI/GTIN: 10195327144982, Lot Number: 22IBR176; c. GYN LAPAROSCOPY CDS-LF, Item Number: CDS981988I, Case UDI/GTIN: 40193489744164, Unit UDI/GTIN: 10193489744163, Lot Number: 22KBF564,22JBV989; d. GYN LAPAROSCOPY, Item Number: CDS982032Y, Case UDI/GTIN: 40195327248858, Unit UDI/GTIN: 10195327248857, Lot Number: 22JBE743; e. GYN LAPAROSCOPY CDS, Item Number: CDS982371G, Case UDI/GTIN: 40193489209397, Unit UDI/GTIN: 10193489209396, Lot Number: 22JBU375,22JBU054; f. UNIVERSAL ROBOTIC ORLANDO, Item Number: CDS982857K, Case UDI/GTIN: 40193489927864, Unit UDI/GTIN: 10193489927863, Lot Number: 22IBA586; g. GYN ROBOTIC CDS, Item Number: CDS982888M, Case UDI/GTIN: 40195327110698, Unit UDI/GTIN: 10195327110697, Lot Number: 22JBK498; h. GYN LAPAROSCOPY CDS-1, Item Number: CDS982892F, Case UDI/GTIN: 40889942216926, Unit UDI/GTIN: 10889942216925, Lot Number: 22JBI848; i. CUH GYN LAPAROSCOPY CDS, Item Number: CDS983206L, Case UDI/GTIN: 40195327164592, Unit UDI/GTIN: 10195327164591, Lot Number: 22JBM358; j. CUH GEN/GYN ROBOTIC CDS, Item Number: CDS983375L, Case UDI/GTIN: 40195327164547, Unit UDI/GTIN: 10195327164546, Lot Number: 22JBI299; k. LAVH CDS-LF, Item Number: CDS983868F, Case UDI/GTIN: 40889942017233, Unit UDI/GTIN: 10889942017232, Lot Number: 22JDB254; l. GYN LAPAROSCOPY CDS

UPC codes

40195327209767, 10195327209766, 40195327144983, 10195327144982, 40193489744164, 10193489744163, 40195327248858, 10195327248857, 40193489209397, 10193489209396, 40193489927864, 10193489927863, 40195327110698, 10195327110697, 40889942216926, 10889942216925, 40195327164592, 10195327164591, 40195327164547, 10195327164546, 40889942017233, 10889942017232, 40193489831345, 10193489831344, 40193489571364, 10193489571363, 40195327175772, 10195327175771, 40195327110841, 10195327110840, 40193489905527, 10193489905526, 40195327043118, 10195327043117, 40195327095667, 10195327095666, 40195327171521, 10195327171520, 40193489962803, 10193489962802

Source

Official record: FDA (Device enforcement) ↗

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