Summary
The FDA issued a Class II for BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C by C.R. Bard Inc. Reason: There is a potential to leak from the catheter where it connects to the drain bag.
Details
Source
Device Recall
External ID
Z-0667-2022
Action Date
2022-03-02
Status
Completed
Category
device
Product Description
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
Lot/Code Info: Serial Number/UDI NGEWX117 (01)00801741183249(17) NGEXX133/(01)00801741183249(17) NGEY0842/(01)00801741183249(17) NGEZ1823/(01)00801741183249(17)
Quantity Affected: 1620 units
Reason for Recall
There is a potential to leak from the catheter where it connects to the drain bag
Distribution
US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-27
Company
Covington, GA
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 122 device recalls issued in the same week, part of 413 device-related FDA actions this month.
C.R. Bard Inc has 78 FDA actions in our database, including 64 recalls and 14 clearances.
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 (C.R. Bard Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does C.R. Bard Inc have FDA actions?
C.R. Bard Inc has 78 FDA actions in our database, including 64 recalls and 14 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0667-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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