Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
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: 1,419 cases (4,349 units) Lot/code info: a. KNEE ARTHROSCOPY CDS-LF, Item Number: CDS940869U, Case UDI/GTIN: 40195327210046, Unit UDI/GTIN: 10195327210045, Lot Number: 22JBR468,22JBA443; b. ARTHROSCOPY CDS, Item Number: CDS985208B, Case UDI/GTIN: 40889942942061, Unit UDI/GTIN: 10889942942060, Lot Number: 22JBR379,22IBS410,22IBO331,22IBO332; c. ARTHROSCOPY LV - EDOC PACK-LF, Item Number: DYNJ0111409L, Case UDI/GTIN: 40889942824015, Unit UDI/GTIN: 10889942824014, Lot Number: 22JMH535,22IMF440; d. ARTHROSCOPY PACK-LF, Item Number: DYNJ0376528J, Case UDI/GTIN: 40889942395935, Unit UDI/GTIN: 10889942395934, Lot Number: 22JBJ567; e. ARTHROSCOPY PACK, Item Number: DYNJ04446N, Case UDI/GTIN: 40888277753649, Unit UDI/GTIN: 10888277753648, Lot Number: 22JMH875,22HMG756; f. ARTHRO PACK-LF, Item Number: DYNJ0637509B, Case UDI/GTIN: 40889942079255, Unit UDI/GTIN: 10889942079254, Lot Number: 22IMH393; g. ARTHROSCOPY PACK-LF, Item Number: DYNJ0751097M, Case UDI/GTIN: 40195327196364, Unit UDI/GTIN: 10195327196363, Lot Number: 22HMC138; h. ARTHROSCOPY PACK-LF, Item Number: DYNJ0890114F, Case UDI/GTIN: 40889942824039, Unit UDI/GTIN: 10889942824038, Lot Number: 22JMC992,22IMG334; i. ARTHROSCOPY KNEE TRAY-LF, Item Number: DYNJ09577J, Case UDI/GTIN: 40889942104803, Unit UDI/GTIN: 10889942104802, Lot Number: 22IBJ738; j. ARTHROSCOPY PACK-LF, Item Number: DYNJ15916C, Case UDI/GTIN: 40888277861610, Unit UDI/GTIN: 10888277861619, Lot Number: 22KBA679,22JBS955; k. ARTHROSCOPY BASIN PACK-LF, Item Number: DYNJ16633C, Case UDI/GTIN: 40888277858
40195327210046, 10195327210045, 40889942942061, 10889942942060, 40889942824015, 10889942824014, 40889942395935, 10889942395934, 40888277753649, 10888277753648, 40889942079255, 10889942079254, 40195327196364, 10195327196363, 40889942824039, 10889942824038, 40889942104803, 10889942104802, 40888277861610, 10888277861619, 40888277858450, 10888277858459, 40884389018423, 10884389018422, 40888277545398, 10888277545397, 40889942605669, 10889942605668, 40888277077745, 10888277077744, 40889942122777, 10889942122776, 40884389363967, 10884389363966, 40889942577027, 10889942577026, 40889942451693, 10889942451692, 40888277554697, 10888277554696
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.