FDAClass IIJune 22, 2016

Vaxcel PICC with PASV Intermediate Safety MST Kit under recall

Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980 The…

Why was Vaxcel PICC with PASV Intermediate Safety MST Kit under 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) 4738829, 2) 4732404, 4749417, 4774464, 4793677, 4819468, 4829479, 3) 4725435, 4745700, 4755306, 4764067, 4801103 & 4827331 with Use By Date 2016-04-30 to 2016-10-31.

Product
Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980 The…
Recalling firm
Navilyst Medical, Inc., an AngioDyamics Company
Quantity
1,127 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)
Open FDA enforcement record Latest recalls