Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348S; 5) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0
Check against the official notice below — it lists the full affected range.
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Reason for recall: The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea. Distribution: US Nationwide. Quantity: 486 kits Lot/code info: 1) DYNJT8784, UDI-DI: 10198459756368(each), 40198459756369(case), Lot Number: 26EBN238; 2) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25GBC553; 3) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25FBA082; 4) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25EBP462; 5) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25DBU966; 6) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25CBS315; 7) DYNJ0369348R, UDI-DI: 10198459442094(each), 40198459442095(case), Lot Number: 25JBB880; 8) DYNJ0369348R, UDI-DI: 10198459442094(each), 40198459442095(case), Lot Number: 25HBF280; 9) DYNJ0369348S, UDI-DI: 10198459656316(each), 40198459656317(case), Lot Number: 26CBK932; 10) DYNJ0369348S, UDI-DI: 10198459656316(each), 40198459656317(case), Lot Number: 26BBT826; 11) DYNJ0369348S, UDI-DI: 10198459656316(each), 40198459656317(case), Lot Number: 26BBT935; 12) DYNJ0369348T, UDI-DI: 10198459733826(each), 40198459733827(case), Lot Number: 26EBG096; 13) DYNJ0369348T, UDI-DI: 10198459733826(each), 40198459733827(case), Lot Number: 26DBM677
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.