Covidien LLC: Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319

Is my product affected?

Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319

• UPC 100000010062

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

What happened

Covidien LLC recalled Vistec X-Ray Detectable Sponges (16 Ply, 8" x 4") due to compromised sterility caused by a breach of the barrier. The recalled product was distributed nationwide in the United States and in Canada, Austria, Belgium, Colombia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Réunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, and the United Kingdom. A total of 372,480 units were affected, identified by lot codes beginning with 100000010062 through lot 15J162962X.

The recall source does not specify a remedy or instructions for what affected consumers should do.

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: 372480 Lot/code info: All lots beginning with 100000010062 through lot 15J162962X

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

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• Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 40342016-03-03
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• 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