BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
Reported: December 19, 2018 Initiated: October 16, 2018 #Z-0596-2019
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.
Details
- Recalling Firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Units Affected
- Box of 4 units
- Distribution
- Distributed to accounts in Florida. Foreign distribution to Great Britain.
- Location
- Glens Falls, NY
Frequently Asked Questions
What product was recalled? ▼
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481. Recalled by Angiodynamics Inc. (Navilyst Medical Inc.). Units affected: Box of 4 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2018. Severity: Moderate. Recall number: Z-0596-2019.
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