Vaxcel PICC with PASV Introducer Kit under the recall
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in…
Why was Vaxcel PICC with PASV Introducer Kit under the recalled?
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
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?
Batch/Lots: 1) 4732403, 4776151, 4792223, 4810671 with Use By 2015-08-31.
- Product
- Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in…
- Recalling firm
- Navilyst Medical, Inc., an AngioDyamics Company
- Quantity
- 210
- Distribution
- Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
- Recall date
- June 22, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)