Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F — Class II medical device recall Z-1967-2016
Terminated recall by Navilyst Medical, Inc., an AngioDyamics Company, reported 2016-06-22, distributed nationwide. PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification ch
| Recall number | Z-1967-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Navilyst Medical, Inc., an AngioDyamics Company, Glens Falls, NY, United States |
| Recall initiated | 2016-03-14 |
| Classified | 2016-06-14 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2018-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 328 units |
| Expiration dates | 2016-03-31 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1967-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.