Device product
Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
Z-1969-2016
Product summary
- Event
- Event 73598
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,786 units
- Official record key
device-enforcement:Z-1969-2016
Official wording
Reason: 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.
Code information: Batch/Lots: 1) 4724924, 4724925 & 4730412 with Use By 2016-03-31. Batch/Lots: 2) 4724929, 4724923, 4725426, 4730400 & 4753766 with Use By Range 2016-03-31 to 2016-07-31. Batch/Lots: 3) 4724927 Use By 2016-03-31.
Distribution pattern: Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
Derived failure modes
-
Unknown
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.