Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling Kerlix X-Ray Detectable Laparotomy Sponges in the 17" x 26" tray pack size (Item Number 4031) due to compromised sterility caused by a breach of the barrier. The recall affects 208,348 units distributed nationwide in the United States and in Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Africa, Spain, Sweden, and the United Kingdom. The affected products include all lots beginning with 110000311162 through lot 15J101262X.
The record does not specify what actions affected consumers should take in response to this recall.
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: 208348 Lot/code info: All lots beginning with 110000311162 through lot 15J101262X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.