MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. H

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: 12,964 cases (23,379 units) Lot/code info: a. EP LAB PACEMAKER PACK, Item Number: 00-401893L, Case UDI/GTIN: 40195327127887, Unit UDI/GTIN: 10195327127886, Lot Number: 22JMC769; b. OPEN HEART CDS, Item Number: CDS840016AD, Case UDI/GTIN: 40193489741842, Unit UDI/GTIN: 10193489741841, Lot Number: 22KBB889; c. OPEN HEART CDS, Item Number: CDS840023T, Case UDI/GTIN: 40193489682060, Unit UDI/GTIN: 10193489682069, Lot Number: 22JBU353,22JBT770; d. AAA CDS, Item Number: CDS840076AC, Case UDI/GTIN: 40195327209620, Unit UDI/GTIN: 10195327209629, Lot Number: 22KBE518; e. OPEN HEART CDS, Item Number: CDS840094N, Case UDI/GTIN: 40195327089512, Unit UDI/GTIN: 10195327089511, Lot Number: 22JBI258,22IBF817; f. PACEMAKER CDS, Item Number: CDS840162V, Case UDI/GTIN: 40193489480628, Unit UDI/GTIN: 10193489480627, Lot Number: 22KBG388,22IBP339; g. HEART CDS, Item Number: CDS840179M, Case UDI/GTIN: 40889942894001, Unit UDI/GTIN: 10889942894000, Lot Number: 22JBJ710,22IBQ944; h. VALVE PACK, Item Number: CDS840187T, Case UDI/GTIN: 40193489816465, Unit UDI/GTIN: 10193489816464, Lot Number: 22JMG653; i. OPEN HEART CDS-3, Item Number: CDS840246N, Case UDI/GTIN: 40889942217428, Unit UDI/GTIN: 10889942217427, Lot Number: 22JLB009,22JLA126,22ILB075; j. OPEN HEART PACK, Item Number: CDS840332Y, Case UDI/GTIN: 40195327259298, Unit UDI/GTIN: 10195327259297, Lot Number: 22KLA079; k. OPEN HEART PACK, Item Number: CDS840393M, Case UDI/GTIN: 40195327188543, Unit UDI/GTIN: 10195327188542, Lot Number: 22KBD842; l. OPEN HEART ADULT, Item Number: CDS84039

UPC codes

40195327127887, 10195327127886, 40193489741842, 10193489741841, 40193489682060, 10193489682069, 40195327209620, 10195327209629, 40195327089512, 10195327089511, 40193489480628, 10193489480627, 40889942894001, 10889942894000, 40193489816465, 10193489816464, 40889942217428, 10889942217427, 40195327259298, 10195327259297, 40195327188543, 10195327188542, 40193489461917, 10193489461916, 40195327255115, 10195327255114, 40195327072231, 10195327072230, 40888277749796, 10888277749795, 40888277814111, 10888277814110, 40889942864660, 10889942864669, 40889942215110, 10889942215119, 40193489817462, 10193489817461, 40195327171422, 10195327171421

Source

Official record: FDA (Device enforcement) ↗

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