FDAClass IISeptember 25, 2013

Central Dressing Change Kit recall

Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1…

Why was Central Dressing Change Kit recalled?

Microbore tubing disconnecting from male luers on the extension sets.

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?

Lot Numbers: 1303022, 1304065

Product
Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1…
Recalling firm
Churchill Medical Systems, Inc.
Quantity
3040
Distribution
Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.
Recall date
September 25, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls