CLASS II Device recall · Reported 19 Dec 2018 · FDA Enforcement Report
BioFlo PICC with Endexo and Pasv, ( RS 5F DL Bioflo Pasv recalled
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling BioFlo PICC with Endexo and Pasv, ( RS 5F DL Bioflo Pasv - Memorial Hospital System (Ltp), distributed in Florida. The recall was initiated on 16 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0596-2019
- FDA event ID
- 81477
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Oct 2018
- FDA classified
- 11 Dec 2018
- Reported
- 19 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Oct 2018 | Recall initiated by company | |
| 11 Dec 2018 | Classified by FDA | +56 days |
| 19 Dec 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.
Product as listed by the FDA
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
Where it was distributed
Distributed to accounts in Florida. Foreign distribution to Great Britain.
Questions about this recall
Why was it recalled?
specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.
Which lots are affected?
5231609
Where was it sold?
Distributed to accounts in Florida. Foreign distribution to Great Britain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 81477This product is part of a recall event; the main page for the event is Xcela Power Injectable PICC with Pasv recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Xcela Power Injectable PICC with Pasv recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Other | FL |
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|---|---|---|---|---|---|
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