Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556
Check against the official notice below — it lists the full affected range.
Covidien LLC has recalled Curity X-Ray Detectable Laparotomy Sponges in the 8" x 36" soft pouch pack size (Item Number 6556) due to compromised sterility caused by a breach in the barrier. The recall affects 87,680 units distributed nationwide in the United States and internationally across 20 countries including Canada, Austria, Belgium, France, Germany, Italy, Spain, Sweden, and the United Kingdom. The affected products are from all lots beginning with 100000055262 through lot 15B223462X.
The compromised sterility of these surgical sponges poses a potential risk to patients who may receive these products during surgical procedures. The recall source does not specify what remedy consumers should pursue.
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: 87680 Lot/code info: All lots beginning with 100000055262 through lot 15B223462X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.