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Recall Observatory FDA recall evidence

Device product

Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711

Z-0595-2019

October 16, 2018

Class II

Product summary

Firm
Angiodynamics Inc. (Navilyst Medical Inc.)
Event
Event 81477
Status
Terminated
Classification
Class II
Quantity
Box of 1 Units
Official record key
device-enforcement:Z-0595-2019

Official wording

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.

Code information: Lot 5096448

Distribution pattern: Distributed to accounts in Florida. Foreign distribution to Great Britain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.