Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
Check against the official notice below — it lists the full affected range.
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Reason for recall: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used. Distribution: US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas. Quantity: 60 Lot/code info: UDI-DI 10198459046551 Lot 25FBU754
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.