Summary
The FDA issued a Class II for PIVO Blood Collection Device 20G, REF: 202-0005 by Velano Vascular. Reason: Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to micr.
Details
Source
Device Recall
External ID
Z-0527-2022
Action Date
2022-02-02
Status
Terminated
Category
device
Product Description
PIVO Blood Collection Device 20G, REF: 202-0005
Lot/Code Info: UDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02
Quantity Affected: 123,700
Reason for Recall
Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection.
Distribution
US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-10
Company
San Francisco, CA
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 97 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Velano Vascular has 2 FDA actions in our database, including 1 recall and 1 clearance.
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 (Velano Vascular) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Velano Vascular have FDA actions?
Velano Vascular has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0527-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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