Z-1969-2016 Class II Terminated
FDA device recall Z-1969-2016 was initiated by Navilyst Medical, Inc., an AngioDyamics Company on March 14, 2016 and is designated Class II. Reason for recall: 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 cathet… The recall status is terminated (terminated June 11, 2018). Affected quantity: 1,786 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 22, 2016
- Initiation Date
- March 14, 2016
- Termination Date
- June 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,786 units
Product Description
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.
Reason for Recall
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.
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.
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.