AVID Medical, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Product may be potentially contaminated with a lubricant used during the manufacturing process.
CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;
1. Model/Item Number (Kit): WRNM035-20; UDI-DI: 10809160489277; Kit Lot Numbers: 1695943; Recalled Supplier Component (in kit): A319516AM; Recalled Supplier Lot Number (in kit): NGKT2391;
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →