Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling Curity X-Ray Detectable Laparotomy Sponges in 18" x 18" tray packs due to compromised sterility caused by a breach of the barrier. The affected product was distributed nationwide throughout the United States and in 20 other countries including Canada, France, Germany, Spain, the United Kingdom, and others. Approximately 996,002 units are involved in the recall, specifically those with lot codes beginning with 110000463762 through lot 15K235262.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Compromised sterility due to breach of barrier
Reason for recall: Compromised sterility due to breach of barrier Distribution: Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom. Quantity: 996002 Lot/code info: All lots beginning with 110000463762 through lot 15K235262
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.