MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDEC

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: 9,079 cases (27,563 units) Lot/code info: a. EAR CDS-LF, Item Number: CDS982612B, Case UDI/GTIN: 40888277899729, Unit UDI/GTIN: 10888277899728, Lot Number: 22JBH351,22JBA043; b. SINUS CDS-1, Item Number: CDS982901F, Case UDI/GTIN: 40889942216971, Unit UDI/GTIN: 10889942216970, Lot Number: 22KBD129; c. ZALE FESS CDS, Item Number: CDS983178F, Case UDI/GTIN: 40195327164639, Unit UDI/GTIN: 10195327164638, Lot Number: 22JBC334,22IBC429; d. ZALE OTOLOGY CDS, Item Number: CDS983181F, Case UDI/GTIN: 40195327164646, Unit UDI/GTIN: 10195327164645, Lot Number: 22IBQ523,22IBJ058; e. ZALE HEAD & NECK CDS, Item Number: CDS983184I, Case UDI/GTIN: 40195327178353, Unit UDI/GTIN: 10195327178352, Lot Number: 22IBO795,22IBJ687; f. CUH PARA/THYROIDECTOMY CDS, Item Number: CDS983209J, Case UDI/GTIN: 40195327179794, Unit UDI/GTIN: 10195327179793, Lot Number: 22JBC280; g. CAM ENDOSCOPIC SINUS/SEPTO CDS, Item Number: CDS983499D, Case UDI/GTIN: 40193489749756, Unit UDI/GTIN: 10193489749755, Lot Number: 22IBU380,22HBW179; h. HEAD AND NECK CDS, Item Number: CDS983910K, Case UDI/GTIN: 40195327256594, Unit UDI/GTIN: 10195327256593, Lot Number: 22JBT244; i. HEAD AND NECK CDS-LF, Item Number: CDS984857J, Case UDI/GTIN: 40195327090808, Unit UDI/GTIN: 10195327090807, Lot Number: 22JDB038,22IDA739; j. NASAL, Item Number: CDS984899G, Case UDI/GTIN: 40193489983822, Unit UDI/GTIN: 10193489983821, Lot Number: 22IBC505; k. ENT SET UP CDS, Item Number: CDS985421G, Case UDI/GTIN: 40193489319300, Unit UDI/GTIN: 10193489319309, Lot Number: 22KBG050,22HBX042; l

UPC codes

40888277899729, 10888277899728, 40889942216971, 10889942216970, 40195327164639, 10195327164638, 40195327164646, 10195327164645, 40195327178353, 10195327178352, 40195327179794, 10195327179793, 40193489749756, 10193489749755, 40195327256594, 10195327256593, 40195327090808, 10195327090807, 40193489983822, 10193489983821, 40193489319300, 10193489319309, 40193489352352, 10193489352351, 40193489451093, 10193489451092, 40889942216629, 10889942216628, 40193489475310, 10193489475319, 40195327270156, 10195327270155, 40193489274494, 10193489274493, 40193489551434, 10193489551433, 40888277854698, 10888277854697, 40193489265683, 10193489265682

Source

Official record: FDA (Device enforcement) ↗

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