Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peri
Summary
The FDA issued a Class II for Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Se by Angiodynamics Inc. (Navilyst Medical Inc.). Reason: Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec)..
Details
Source
Device Recall
External ID
Z-2617-2021
Action Date
2021-10-06
Status
Terminated
Category
device
Product Description
Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995
Lot/Code Info: Lot Number: 5210162 (UDI): H96560M7019951
Quantity Affected: 4 boxes (5/each)= 20 eaches
Reason for Recall
Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
Distribution
Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2017-10-17
Company
Glens Falls, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Angiodynamics Inc. (Navilyst Medical Inc.)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Angiodynamics Inc. (Navilyst Medical Inc.) have FDA actions?
This is the only FDA action we have on record for Angiodynamics Inc. (Navilyst Medical Inc.) in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2617-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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