Vaxcel PICC with PASV Introducer Kit under the recall
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxcel PICC with…
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) 4714745 with Use By 2016-03-31. Batch/Lots: 2) 4745413, 4819467, 4827954, 4725425 & 4726948 with Use By Date Range 2016-03-31 to 2016-11-30.
- Product
- Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxcel PICC with…
- Recalling firm
- Navilyst Medical, Inc., an AngioDyamics Company
- Quantity
- 328 units
- 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)