Covidien LLC: Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321

Is my product affected?

Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321

• UPC 100000009962

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

What happened

Covidien LLC is recalling Vistec X-Ray Detectable Sponges in the 26 Ply, 8" x 4" size due to compromised sterility caused by a breach of the barrier. The affected sponges were distributed nationwide in the United States and internationally to Canada, Austria, Belgium, Columbia, 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 199,488 units are affected, identified by lot numbers beginning with 100000009962 through lot 15J163262X.

The source document does not specify what remedy is available to consumers who have purchased or used these sponges.

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: 199488 Lot/code info: All lots beginning with 100000009962 through lot 15J163262X

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