Recall Z-0595-2019— Angiodynamics Inc. (Navilyst Medical Inc.)

Name: FDA recall Z-0595-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-16

Class II · Terminated

Class II FDA medical device recall by Angiodynamics Inc. (Navilyst Medical Inc.), initiated 2018-10-16, terminated 2020-06-26. It names one FDA 510(k) clearance: K091261. Product: Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711. Reason: 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..

Recalling firm: Angiodynamics Inc. (Navilyst Medical Inc.)
Classification: Class II
Status: Terminated
Initiated: 2018-10-16
Terminated: 2020-06-26
Firm location: Glens Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K091261 — NMI PICCNavilyst Medical, Inc.·cleared 2009-05-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.