MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CD

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: 62,930 cases (215,456 units) Lot/code info: a. BASIN SET-UP PACK, Item Number: BAD079F, Case UDI/GTIN: 40889942614135, Unit UDI/GTIN: 10889942614134, Lot Number: 22IBR514; b. LAP CHOLE CDS, Item Number: CDS860230D, Case UDI/GTIN: 40888277749376, Unit UDI/GTIN: 10888277749375, Lot Number: 22JMG555; c. MAJOR CDS, Item Number: CDS980178G, Case UDI/GTIN: 40888277906458, Unit UDI/GTIN: 10888277906457, Lot Number: 22JMG570,22JMC877; d. UROLOGY MINOR CDS, Item Number: CDS980371L, Case UDI/GTIN: 40195327050956, Unit UDI/GTIN: 10195327050955, Lot Number: 22HBU946; e. UROLOGY MAJOR CDS, Item Number: CDS980383O, Case UDI/GTIN: 40195327251193, Unit UDI/GTIN: 10195327251192, Lot Number: 22JBV588; f. SINGLE BASIC CDS, Item Number: CDS980389O, Case UDI/GTIN: 40195327231607, Unit UDI/GTIN: 10195327231606, Lot Number: 22JMF540; g. ORGAN RECOVERY CDS, Item Number: CDS980556F, Case UDI/GTIN: 40888277793836, Unit UDI/GTIN: 10888277793835, Lot Number: 22JBO588,22IBV960; h. GENERAL ABD CDS, Item Number: CDS980628I, Case UDI/GTIN: 40193489540667, Unit UDI/GTIN: 10193489540666, Lot Number: 22IMG415; i. BURN CDS, Item Number: CDS980629J, Case UDI/GTIN: 40193489540377, Unit UDI/GTIN: 10193489540376, Lot Number: 22JMG578; j. MINOR, Item Number: CDS980749G, Case UDI/GTIN: 40888277977496, Unit UDI/GTIN: 10888277977495, Lot Number: 22IBE725; k. MAJOR VASCULAR, Item Number: CDS980752I, Case UDI/GTIN: 40889942428541, Unit UDI/GTIN: 10889942428540, Lot Number: 22JBU157,22JBB126; l. BASIC CORE CDS, Item Number: CDS982062F, Case UDI/GTIN: 40193489648431

UPC codes

40889942614135, 10889942614134, 40888277749376, 10888277749375, 40888277906458, 10888277906457, 40195327050956, 10195327050955, 40195327251193, 10195327251192, 40195327231607, 10195327231606, 40888277793836, 10888277793835, 40193489540667, 10193489540666, 40193489540377, 10193489540376, 40888277977496, 10888277977495, 40889942428541, 10889942428540, 40193489648431, 10193489648430, 40193489775533, 10193489775532, 40888277737076, 10888277737075, 40193489418201, 10193489418200, 40889942217411, 10889942217410, 40889942216933, 10889942216932, 40889942217459, 10889942217458, 40889942926764, 10889942926763, 40889942926672, 10889942926671

Source

Official record: FDA (Device enforcement) ↗

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