PlainRecalls
FDA Devices Moderate Class II Terminated

Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534

Reported: June 8, 2016 Initiated: March 3, 2016 #Z-1855-2016

Product Description

Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534

Reason for Recall

Compromised sterility due to breach of barrier

Details

Recalling Firm
Covidien LLC
Units Affected
350550
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.
Location
North Haven, CT

Frequently Asked Questions

What product was recalled?
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534. Recalled by Covidien LLC. Units affected: 350550.
Why was this product recalled?
Compromised sterility due to breach of barrier
Which agency issued this recall?
This recall was issued by the FDA Devices on June 8, 2016. Severity: Moderate. Recall number: Z-1855-2016.