Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Summary
The FDA issued a Class II for Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray by C.R. Bard Inc. Reason: There is potential for packaging defects that may impact the sterile barrier..
Details
Source
Device Recall
External ID
Z-2529-2021
Action Date
2021-09-29
Status
Ongoing
Category
device
Product Description
Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Lot/Code Info: Catalog A800061, Lot NGFR3658, UDI (01)00801741104848(17)251228(10)
Quantity Affected: 2660 units
Reason for Recall
There is potential for packaging defects that may impact the sterile barrier.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-05
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 173 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-2529-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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