Medline Industries, LP: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF, M

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: 4324 kits Lot/code info: Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22EMB486; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22CMI117; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22CMB218; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22CMB219; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21LMA406; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21LMA805; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21JMF667; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21IMF752; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21HMG136; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21HMB278; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21GMD367; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21CKA503; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21AKA471; Medli

UPC codes

10193489815122, 40193489815123, 10193489846058, 40193489846059, 10195327040284, 40195327040285, 10195327154738, 40195327154739, 10195327276041, 40195327276042

Source

Official record: FDA (Device enforcement) ↗

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