Z-0596-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 19, 2018
- Initiation Date
- October 16, 2018
- Termination Date
- June 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Box of 4 units
Product Description
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
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
5231609