Xcela Hybrid PICC with PASV Valve Technology — Class II medical device recall Z-1978-2016
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-1978-2016 |
|---|---|
| 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 | 100 units |
| Lot numbers | 4746868, 4752404, 4759481, 4788361, 4807952 |
| Expiration dates | 2015-08-31 |
Product
Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
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-1978-2016. 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.