Lower riskMedical device recall · FDA · Published October 16, 2018
Angiodynamics Xcela Power PICC Kit: Incorrect Expiration Dates Recalled
Angiodynamics recalls Xcela Power PICC kits with incorrect expiration dates that could lead to use beyond validated shelf life. Affected kits may need replacement to ensure safety.
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.
Take action
Contact the company
📍Recalling firmAngiodynamics Inc. (Navilyst Medical Inc.)10 Glens Falls Tech Park · Glens Falls, NY 12801-3864
“Angiodynamics Xcela Power PICC Kit: Incorrect Expiration Dates Recalled.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69623-angiodynamics-xcela-power-picc-kit-incorrect-expiration-dates-recalled. Based on FDA recall #Z-0595-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0595-2019%22&limit=1).
The FDA announced on 2018-10-16 that Angiodynamics Inc. (Navilyst Medical Inc.) is recalling specific lots of Xcela Power Injectable PICC catheters due to incorrect expiration dates that extend shelf life beyond validated testing limits. According to the FDA, removal of the affected product is warranted to prevent use beyond the validated expiry date.
How to tell if you have it
Brand: Angiodynamics
Product: Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG)
Catalog no.: 55-711
Lot code: 5096448
The hazard
Specific lots of the recalled catheters are labelled with incorrect expiration dates that extend the shelf life beyond the date supported by validation testing. The FDA stated that removal is warranted to prevent use beyond the validated expiry date, although the product has not yet reached its validated expiry date.
Context
GovInfoNow's records show Angiodynamics Inc. (Navilyst Medical Inc.) has 8 other recalls on record since 2017-10-17. Other recent recalls of similar products include Angiodynamics Smart Port CT-Implantable Port Recall: Sterility Risk (2021-02-22), Starburst Talon Electrosurgical Device Recalled for Incorrect Labeling (2019-10-02), and Angiodynamics BIOFLO 8F Device May Delay Implantation Due to Connector Issue (2019-09-18). Other recent recalls of similar products include Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation: Incorrect Use-By-Dates (2026-05-13), Medtronic Pocket Adaptor Kits with Incorrect Use-By Dates Recalled (2026-05-13), and Inspire Stimulation Lead Recall: Incorrect Use By Date Extends Shelf Life Risk (2026-05-11).
How to tell if you have this one
Check for the Xcela Power PICC kit with model XCELA PASV 4F SL 55CM Catheter Kit CE PG, lot number 5096448. The product was sold with incorrect expiration dates.
Brand
Angiodynamics
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Distributed to accounts in Florida. Foreign distribution to Great Britain.
Recall number
Product, codes & lots
Quantity
Z-0595-2019
Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711; Lot 5096448
Box of 1 Units
Z-0596-2019
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481; 5231609
Box of 4 units
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the lot number on the kit label to confirm if it matches the affected lot 5096448.
Where it went and when
Where it was distributed
Distributed in Florida, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distributed to accounts in Florida. Foreign distribution to Great Britain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0595-2019 (October 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0595-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.