Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling Curity Gauze Sponges, 16 ply 4" x 4" sterile gauze pads (Item Number 397310) distributed nationwide in the United States and internationally to Canada, Austria, Belgium, Colombia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, and the United Kingdom. The recall affects approximately 713,600 units across all lots beginning with 110000037462 through Lot 120002259962.
The gauze sponges are being recalled because the sterile barrier has been compromised, which could affect the sterility of the product. These gauze pads are designed for use inside the body or on surgical incisions. The recall record does not specify what action affected consumers should take or what remedy is available.
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: 713600 Lot/code info: All lots beginning with 110000037462 through Lot 120002259962
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.