Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling Curity X-Ray Detectable Laparotomy Sponges in the 18" x 18" soft pouch pack (Item Number 6522) due to compromised sterility caused by a breach in the barrier. The recall affects over 3.1 million units distributed across the United States and 20 other countries including Canada, France, Germany, the United Kingdom, and others. All lots beginning with lot code 110000161662 through lot 15G255462X are included in this recall.
The recall covers sponges that may not maintain their sterility guarantee, which is critical since these products are used in surgical settings where contamination poses serious health risks. The product was distributed nationwide in the US as well as internationally. 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: 3152197 Lot/code info: All lots beginning with 110000161662 through lot 15G255462X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.