Medline Industries, LP: Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.

Hazard

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Details from the source

Reason for recall: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. Distribution: Worldwide distribution. Quantity: 1552486 kits Lot/code info: Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 23CBR748; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22LBP661; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22JBI816; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22JBI817; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22GBG444; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22GBG445; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22FBM376; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22DBB694; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22DBA187; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 21LBP574; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 21JBU289; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 21FBS507; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 21FBL891; Medline Kit Number/SKU CDS78004

UPC codes

10193489355406, 40193489355407, 10195327362638, 40195327362639, 10889942766840, 40889942766841, 10198459237294, 40198459237295, 10198459624636, 40198459624637, 10193489820881, 40193489820882, 10195327040437, 40195327040438, 10195327642556, 40195327642557, 10889942714506, 40889942714507, 10195327663636, 40195327663637, 10198459447273, 40198459447274, 10195327051877, 40195327051878, 10195327663407, 40195327663408, 10198459447280, 40198459447281, 10198459593314, 40198459593315, 10195327534400, 40195327534401, 10198459286339, 40198459286330, 10198459635885, 40198459635886, 10193489332520, 40193489332521, 10195327065263, 40195327065264

Source

Official record: FDA (Device enforcement) ↗

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