Vistec X-Ray Detectable Sponges recall: Sterility Concern
Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
Why was Vistec X-Ray Detectable Sponges recalled?
Compromised sterility due to breach of barrier
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots beginning with 100000010062 through lot 15J162962X
- Product
- Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
- Recalling firm
- Covidien LLC
- Quantity
- 372480
- 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.
- Recall date
- June 8, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)