FDAFDA · Food and drugs·Recall number Z-1855-2016
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534
Published June 8, 2016 · Recall initiated: March 3, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Compromised sterility due to breach of barrier
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LLC
- Distributor
- 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.
- Lot
- All lots beginning with 110000476162 through lot 15J070162X
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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