Covidien LLC: Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034

Is my product affected?

Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034

• UPC 110000142862

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

What happened

Covidien LLC is recalling Kerlix X-Ray Detectable Laparotomy Sponges in 16" x 17" tray packs due to compromised sterility caused by a breach of the barrier. The recalled product was 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. A total of 114,720 units were affected, including all lots beginning with lot number 110000142862 through lot number 130002191062X.

The recall notice does not specify a remedy or instructions for affected consumers to follow.

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: 114720 Lot/code info: All lots beginning with 110000142862 through lot 130002191062X

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
• 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
• 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