Medline Industries, LP: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642

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: 7004 kits Lot/code info: Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 22BBJ540; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21LBM539; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21IBX286; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21HBM832; Medline Kit Number/SKU DYNJ47491F: UDI/DI each10193489586725, UDI/DI case 40193489586726, Lot Number: 21KMD114; Medline Kit Number/SKU DYNJ58274: UDI/DI each10889942840724, UDI/DI case 40889942840725, Lot Number: 22FMI371; Medline Kit Number/SKU DYNJ58274: UDI/DI each10889942840724, UDI/DI case 40889942840725, Lot Number: 21IMD775; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23JBD782; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23HBY508; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23GBQ615; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23EBR984; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23EBD017; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23BBO048; Medline Kit Number/SKU DYNJ58344: UDI/DI each1088994

UPC codes

40889942469650, 40193489586726, 40889942840725, 40889942841722, 40884389201641

Source

Official record: FDA (Device enforcement) ↗

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