Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522
This recall has been terminated (originally issued May 31, 2016).
- Company
- Covidien Llc
- Recall Initiated
- March 3, 2016
- Posted
- May 31, 2016
- Terminated
- June 15, 2017
- Recall Number
- Z-1854-2016
- Quantity
- 3152197
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
All lots beginning with 110000161662 through lot 15G255462X
Root Cause
Packaging process control
Action Taken
Covidien initiated recall by letter on March 4, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878