MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITH

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: 1,258 cases (2,154 units) Lot/code info: a. GYN ABD CDS, Item Number: CDS830215G, Case UDI/GTIN: 40889942110040, Unit UDI/GTIN: 10889942110049, Lot Number: 22IMD263; b. LAVH PROCEDURE, Item Number: CDS980754R, Case UDI/GTIN: 40195327008698, Unit UDI/GTIN: 10195327008697, Lot Number: 22JME637; c. TAH CDS, Item Number: CDS982249I, Case UDI/GTIN: 40193489651264, Unit UDI/GTIN: 10193489651263, Lot Number: 22JBM626,22JBK303; d. CUH LITHOTOMY CDS, Item Number: CDS983207M, Case UDI/GTIN: 40195327164608, Unit UDI/GTIN: 10195327164607, Lot Number: 22JBM359; e. LAVH CDS, Item Number: CDS983455C, Case UDI/GTIN: 40193489413114, Unit UDI/GTIN: 10193489413113, Lot Number: 22HBU206,22HBU964; f. GROTH VAGINAL CDS, Item Number: CDS984201T, Case UDI/GTIN: 40195327143986, Unit UDI/GTIN: 10195327143985, Lot Number: 22IBA054; g. MAJOR LITHOTOMY, Item Number: CDS985547N, Case UDI/GTIN: 40193489899925, Unit UDI/GTIN: 10193489899924, Lot Number: 22JBN433,22IBE548; h. MAJOR VAGINAL HARPER PACK-LF, Item Number: DYNJ0161768F, Case UDI/GTIN: 40195327171507, Unit UDI/GTIN: 10195327171506, Lot Number: 22IDC076,22IDA825,22IDA274; i. VAG. HYST TRAY-LF, Item Number: DYNJ0209066N, Case UDI/GTIN: 40889942054429, Unit UDI/GTIN: 10889942054428, Lot Number: 22JME324; j. VAGINAL HYSTERECTOMY PACK-LF, Item Number: DYNJ0373807K, Case UDI/GTIN: 40195327225682, Unit UDI/GTIN: 10195327225681, Lot Number: 22JBO175; k. HYSTERECTOMY PACK-LF, Item Number: DYNJ20485L, Case UDI/GTIN: 40195327024360, Unit UDI/GTIN: 10195327024369, Lot Number: 22IDA372; l. HYSTERECTO

UPC codes

40889942110040, 10889942110049, 40195327008698, 10195327008697, 40193489651264, 10193489651263, 40195327164608, 10195327164607, 40193489413114, 10193489413113, 40195327143986, 10195327143985, 40193489899925, 10193489899924, 40195327171507, 10195327171506, 40889942054429, 10889942054428, 40195327225682, 10195327225681, 40195327024360, 10195327024369, 40888277763525, 10888277763524, 40195327148196, 10195327148195, 40889942215929, 10889942215928, 40888277073266, 10888277073265, 40193489729994, 10193489729993, 40193489313766, 10193489313765, 40193489944229, 10193489944228, 40193489996945, 10193489996944, 40889942444602, 10889942444601

Source

Official record: FDA (Device enforcement) ↗

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