Covidien LLC: Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047

Is my product affected?

Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047

• UPC 110000233562

Check against the official notice below — it lists the full affected range.

What happened

Covidien LLC is recalling Curity All Purpose Sponges (Non-woven, 4 Ply, Soft Pouch, 4" x 4") across the United States and 20 other countries due to compromised sterility caused by a breach in the barrier. The recall affects approximately 2.4 million units with lot codes beginning with 110000233562 through 120002651262X.

The recall notice does not specify a remedy or instructions for consumers affected by this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Compromised sterility due to breach of barrier

Details from the source

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: 2418560 Lot/code info: All lots beginning with 110000233562 through lot 120002651262X

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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.2016-03-03
• Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 40342016-03-03
• Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 40312016-03-03
• Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 40372016-03-03
• Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 60222016-03-03

All FDA (Device enforcement) recalls