Medline Industries, LP: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number

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: 21288 kits Lot/code info: Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25EDA675; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25CDA718; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25BDA328; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 24KDB408; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 24KDA607; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23HMH658; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23GMD341; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23EMB793; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23CMG372; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23BMI499; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22JMF967; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22EMC648; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22CMD889; Medline Kit Number/SKU DYNJ0247

UPC codes

10198459000218, 40198459000219, 10195327119478, 40195327119479, 10195327371319, 40195327371310, 10198459311321, 40198459311322, 10195327587260, 40195327587261, 10193489895896, 40193489895897, 10193489603576, 40193489603577, 10195327286460, 40195327286461, 10193489925388, 40193489925389, 10195327632458, 40195327632459, 10195327318079, 40195327318070, 10889942745807, 40889942745808, 10195327070328, 40195327070329, 10889942945993, 40889942945994, 10889942215904, 40889942215905, 10195327107802, 40195327107803, 10195327106997, 40195327106998, 10889942368105, 40889942368106, 10889942235742, 40889942235743, 10193489755589, 40193489755580

Source

Official record: FDA (Device enforcement) ↗

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