Z-0595-2019 Class II Terminated
FDA device recall Z-0595-2019 was initiated by Angiodynamics Inc. (Navilyst Medical Inc.) on Oct 16, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jun 26, 2020). Affected quantity: Box of 1 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 19, 2018
- Initiation Date
- Oct 16, 2018
- Termination Date
- Jun 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Box of 1 Units
Product Description
Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
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.
Distribution Pattern
Distributed to accounts in Florida. Foreign distribution to Great Britain.
Code Information
Lot 5096448
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0595-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026