Covidien LLC: Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545

Is my product affected?

Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545

• UPC 110001420362

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

What happened

Covidien LLC recalled Curity X-Ray Detectable Laparotomy Sponges in the 4" x 18" soft pouch pack format due to compromised sterility caused by a breach in the barrier. The recall affects 70,960 units distributed nationwide in the United States and internationally across 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 affected products have lot codes beginning with 110001420362 through lot 15C151862X.

The recall notice does not specify a remedy or instructions for consumers regarding what actions they should take in response to this recall.

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: 70960 Lot/code info: All lots beginning with 110001420362 through lot 15C151862X

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
• Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 80472016-03-03
• 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

All FDA (Device enforcement) recalls