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FDA (Device enforcement)Recalled 2016-03-03closedclass ii

Covidien LLC: Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056

Is my product affected?

Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056

  • UPC 110001358162

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

What happened

Covidien LLC is recalling Curity X-Ray Detectable Laparotomy Sponges in the 8" x 36" tray pack size (Item Number 6056) because the sterile barrier has been compromised. A total of 36,040 units were distributed across the United States and 20 other countries including Canada, Austria, Belgium, France, Germany, Italy, Spain, Sweden, the United Kingdom, and others. The affected products are from all lots beginning with code 110001358162 through lot 15C033262X.

The source document does not specify a remedy or what an affected consumer 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: 36040 Lot/code info: All lots beginning with 110001358162 through lot 15C033262X

Source

Official record: FDA (Device enforcement) ↗

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

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