Medline Industries, LP: Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, 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: 486946 kits Lot/code info: Medline Kit Number/SKU AM310B: UDI/DI each 10193489242126, UDI/DI case 40193489242127, Lot Number: 20XBG776; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23JBF547; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23GBK604; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBO915; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBD581; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABP476; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABD648; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22LBE888; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22HBL188; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22HBF976; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22FBN678; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22DBK641; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22BBU367; Medline Kit Number/SKU CDS980579D:

UPC codes

10193489242126, 40193489242127, 10889942133710, 40889942133711, 10198459027734, 40198459027735, 10884389647141, 40884389647142, 10193489520415, 40193489520416, 10195327004156, 40195327004157, 10195327657468, 40195327657469, 10198459385490, 40198459385491, 10193489712209, 40193489712200, 10195327069742, 40195327069743, 10889942216970, 40889942216971, 10198459392917, 40198459392918, 10193489363128, 40193489363129, 10195327185282, 40195327185283, 10195327433567, 40195327433568, 10195327627393, 40195327627394, 10193489237351, 40193489237352, 10198459479779, 40198459479770, 10198459579738, 40198459579739, 10193489577624, 40193489577625

Source

Official record: FDA (Device enforcement) ↗

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