Z-2525-2021Class II

Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization...

Name: Z-2525-2021 Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization...
Creator: C.R. Bard Inc
Published: 2021-08-05
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2021-08-05 / Open, Classified / root cause: packaging

FDA source

C.R. Bard Inc began a recall of Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device on 2021-08-05. FDA classified it as Class II and gives the reason as "There is potential for packaging defects that may impact the sterile barrier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2525-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-05
Posted: 2021-09-23
Recalling firm: C.R. Bard Inc
Product: Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Product code: MJC Catheter, Urological (Antimicrobial) And Accessories
Reason for recall: There is potential for packaging defects that may impact the sterile barrier.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Customer letters were sent "URGENT MEDICAL DEVICE RECALL" via FedEx and email to affected consignees on August 13, 2021. Customers are asked to please Take the Following Actions: 1. Note that there may be a supply disruption in Foley catheter trays from all sources due to the current product shortage driven by this issue and other issues with third party Foley manufacturers. 2. Please check all inventory locations within your institution for the specific catalog and lot number combinations listed in Attachment 1 of this recall notice. 3. Share this recall notice with any users of the product, within your facilities, to ensure they are also aware of this recall notice. 4. If you purchased this product from a distributor, contact your distributor for further instructions. 5. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification and process any applicable order credit. 6. Report any adverse health consequences experienced with the use of this product to BD at the contact information below. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program BD will process order credits, including shipping costs, for all customers discontinuing use of and returning product as a result of this notification, following receipt of the completed Customer Response Form. BD has implemented actions to prevent recurrence of this product issue. The firm, BD, sent an updated letter dated October 8, 2021 informing customers of additional affected lot numbers that were distributed between March 2021 through July 23, 2021.
Quantity in commerce: 11,600 units
Distribution: US Nationwide distribution.
Product codes and lots: Catalog A303316A, Lots: NGEVX103 (exp. 08/31/2022), UDI (01)00801741073793(17)201220(10); NGFR3290 (02/28/2023), UDI (01)00801741073793(17)201220(10); NGFR3291 (exp. 02/28/2023), UDI (01)00801741073793(17)201220(10); and NGFR4542 (exp. 02/28/2023) UDI (01)00801741073793(17)201220(10)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2525-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2521-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2522-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2523-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2524-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2525-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2526-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2527-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2528-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2529-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2530-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2531-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2532-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2533-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2534-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2535-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2536-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2537-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2538-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2539-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2540-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23
Z-2541-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23

Product code MJC

K040658Class IIBardex I.c. Latex Foley CatheterC.R. Bard, Inc. / cleared 2004-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)