MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-1095-2023)
See the recall detail below. You can also see other recalls from the same firm in 2023.
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLOGY PACK l. OCULOPLASTIC PACK m. BLEPH PACK n. EYE PACK o. OCULAR PLASTIC PACK p. OCULOPLASTIC PACK
Class II
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
a. BASIC EYE PACK-LF, Item Number: DYNJ0842521C, Case UDI/GTIN: 40193489352383, Unit UDI/GTIN: 10193489352382, Lot Number: 22JDA005,22HDC265; b. VITRECTOMY PACK-LF, Item Number: DYNJ0843936F, Case UDI/GTIN: 40193489352390, Unit UDI/GTIN: 10193489352399, Lot Number: 22JDA822,22IDB984; c. EYE PACK-EAST-LF, Item Number: DYNJ14064, Case UDI/GTIN: 40080196931102, Unit UDI/GTIN: 10080196931101, Lot Number: 22JBC143,22IBF606; d. OSC OCULAR PLASTIC PACK-LF, Item Number: DYNJ31639B, Case UDI/GTIN: 40889942292067, Unit UDI/GTIN: 10889942292066, Lot Number: 22JBG389,22HBY420; e. EYE PACK, Item Number: DYNJ35056A, Case UDI/GTIN: 40889942227564, Unit UDI/GTIN: 10889942227563, Lot Number: 22JBL816; f. OCULOPLASTIC PACK, Item Number: DYNJ46539J, Case UDI/GTIN: 40193489997355, Unit UDI/GTIN: 10193489997354, Lot Number: 22JME546,22JME931; g. EYE PLASTIC PACK, Item Number: DYNJ47859C, Case UDI/GTIN: 40193489916066, Unit UDI/GTIN: 10193489916065, Lot Number: 22JBS972; h. PLASTIC EYE PACK, Item Number: DYNJ49413A, Case UDI/GTIN: 40888277971593, Unit UDI/GTIN: 10888277971592, Lot Number: 22KBA929; i. DR H BLEPH PACK, Item Number: DYNJ54487A, Case UDI/GTIN: 40193489587877, Unit UDI/GTIN: 10193489587876, Lot Number: 22HBG403; j. BLEPH PACK, Item Number: DYNJ62174A, Case UDI/GTIN: 40195327037780, Unit UDI/GTIN: 10195327037789, Lot Number: 22IBT956; k. OPHTHALMOLOGY PACK, Item Number: DYNJ63785, Case UDI/GTIN: 40193489760744, Unit UDI/GTIN: 10193489760743, Lot Number: 22IBN397; l. OCULOPLASTIC PACK, Item Number: DYNJ66365, Case UDI/GTIN: 40193489346627, Unit UDI/GTIN: 10193489346626, Lot Number: 22JBE699; m. BLEPH PACK, Item Number: DYNJ67875, Case UDI/GTIN: 40193489448826, Unit UDI/GTIN: 10193489448825, Lot Number: 22JBY558,22JBY531; n. EYE PACK, Item Number: DYNJ69446, Case UDI/GTIN: 40193489942546, Unit UDI/GTIN: 10193489942545, Lot Number: 22IBS350,22HBN241; o. OCULAR PLASTIC PACK, Item Number: DYNJ82588, Case UDI/GTIN: 40195327198795, Unit UDI/GTIN: 10195327198794, Lot Number: 22HBJ348; p. OCULOPLASTIC PACK, Item Number: DYNJ908778, Case UDI/GTIN: 40195327177660, Unit UDI/GTIN: 10195327177669, Lot Number: 22JBW843
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Voluntary: Firm initiated