Medline Industries, LP: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit N

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: 2228 kits Lot/code info: Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23JMB165; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23CMH103; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23BMH200; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23BMB495; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 22KMH108; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 22KME285; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23KMJ648; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 26BME013; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25JMC725; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25IMA571; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25HMC497; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25FMG199; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25EMB523; Medli

UPC codes

10195327267407, 40195327267408, 10195327643713, 40195327643714, 10198459674907, 40198459674908, 10195327191689, 40195327191680, 10195327671136, 40195327671137, 10198459059216, 40198459059217, 10198459334146, 40198459334147, 10198459568817, 40198459568818

Source

Official record: FDA (Device enforcement) ↗

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