Medline Industries, LP recalls Medline medical procedure kits, containing Medline Neuro Spo
See all recalls from Medline Industries, LP →Recalled Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D; 3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.
Hazard / Issue
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.
Issued by
FDA
Distribution: Worldwide distribution.
Lot/Code Info: Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23IME618; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23FMF542; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23DMA094; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23AMD730; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22GMB685; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22DMI233; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22DMC612; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 24AMA230; Medline Kit Number/SKU DYNJ51637D: UDI/DI each 10195327632106, UDI/DI case 40195327632107, Lot Number: 24GMI248; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23JMK002; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23JME739; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23IBJ883; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23EBO648; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23ABT378; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22KBG029; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22JBF057; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22IBL935; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22FBD348; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22DBP280; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22BBB689; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22ABT749; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21KBX317; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21JBZ013; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21JBB969; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21IBB479; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21GBL057; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21BBL823; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 26AMH608; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25LMB913; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25HMI678; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25GMK494; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25FMH605; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25DMA861; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25BMB215; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24JMJ380; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24FMD882; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24EMD977; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24DMF834; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24BMJ374; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23LMF318.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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