| | Class 2 Device Recall Bard Foley/SureStep Foley Trays |  |
| Date Initiated by Firm | June 25, 2026 |
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| Date Posted | September 04, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3116-2026 |
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| Recall Event ID |
98840 |
| 510(K)Number | K040658 K910318 K984136 |
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| Product Classification |
Catheter, Urological (Antimicrobial) And Accessories - Product Code MJC
|
| Product | Products that contain the Pericare Wipes:
*Bardex I.C. Complete Care Foley Catheter Tray
REF: 300316A
UDI codes: 00801741024344 10801741024341
*Bardex I.C. Complete Care Foley Catheter Tray and Urine Meter
REF:
303314A
303316A
303318A
UDI code:
00801741024252 10801741024259
00801741024269 10801741024266
00801741024276 10801741024273
*SureStep" Foley Tray System Bardex IC Complete Care
REF: A300314A
UDI codes: 00801741073724 10801741073721
REF: A300314AC (Canada Only)
UDI-DI code: 00801741143243
*SureStep" Foley Tray System Bardex IC Complete Care
REF: A300316A
UDI code: 00801741073731 10801741073738
*SureStep" Foley Tray System Bardex IC Complete Care
REF: A300318A
UDI code: 00801741073748 10801741073745
*SureStep" Foley Tray System Bardex IC Complete Care
REF:
A303314A
A303316A
A303318A
UDI code:
00801741073786 10801741073783
00801741073793 10801741073790
00801741073809 10801741073806
*SureStep" Foley Tray System Lubri-Sil IC Complete Care
REF: A303414A
UDI code: 00801741073816 10801741073813
*(416A)SureStep" Foley Tray System Bardex IC Complete Care
(714A/716A/718A)SureStep" Foley Tray System Bardex IC Complete Care
(914)SureStep" Foley Tray System
REF:
A304716A
A304714A
A304716A
A304718A
UDI code:
00801741104206 10801741104203
00801741104268 10801741104265
00801741104299 10801741104296
00801741100376 10801741100373
*SureStep" Foley Tray System Bardex IC Complete Care
REF: A319416A
UDI code: 00801741100307 10801741100304
*SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter
REF: A319416AM
UDI code: 00801741073861 10801741073868
*SureStep" Foley Tray System Bardex IC Complete Care
REF: A319418A
UDI code: 00801741100314 10801741100311
SureStep" Foley Tray System Bardex IC Complete Care
REF: A903316A
UDI code: 00801741096600 10801741096607
*****
SureStep" Foley Tray System Lubri-Sil IC Complete Care
REF: A300414A
UDI code: 00801741073755 10801741073752
SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter
REF: A319414AM
UDI code: 00801741073854 10801741073851
SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter
REF: A319418AM
UDI code: 00801741073878 10801741073875
SureStep" Foley Tray System Bardex IC Complete Care
REF: A903318A
UDI code: 00801741104657 10801741104654
For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine. |
|---|
| Code Information |
Bardex¿ I.C. Complete Care¿ Foley Catheter Tray
300316A / 00801741024344¿ 10801741024341
Lot Number: NGKT3657
Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter
303314A / 00801741024252¿ 10801741024259
Lot Number: NGKU4153
303316A / 00801741024269 10801741024266
Lot Number: NGKW2883
303318A / 00801741024276¿ 10801741024273
Lot Number: NGKU0966
*SureStep" Foley Tray System Bardex¿ IC Complete Care¿
A300314A / 00801741073724¿ 10801741073721
Lot Number: NGKU1020
A300314AC (Canada Only) / 00801741143243
Lot Number: ****
SureStep" Foley Tray System Bardex¿ IC Complete Care¿
A300316A / 00801741073731 10801741073738
Lot Numbers:
NGKT2448
NGKT3221
NGKT3288
NGKT3301
NGKT3315
NGKU2921
NGKV0293
SureStep" Foley Tray System Bardex¿ IC Complete Care¿
A300318A / 00801741073748¿ 10801741073745
Lot Number: NGKT2493
SureStep" Foley Tray System Bardex¿ IC Complete Care¿
A303314A / 00801741073786¿ 10801741073783
Lot Numbers:
NGKT3222
NGKV0249
A303316A / 00801741073793¿ 10801741073790
Lot Numbers:
NGKU0894
NGKU0947
NGKU0973
NGKU1021
NGKU1748
NGKU1826
NGKU1830
NGKU2034
NGKU2035
NGKU2996
NGKU3042
NGKU3969
NGKU4037
NGKU4077
NGKU4078
NGKU4135
NGKU4713
NGKU4714
NGKU4720
NGKU4721
NGKU4722
NGKU4727
NGKV2390
NGKV3390
A303318A / 00801741073809¿ 10801741073806
Lot Numbers:
NGKT3223
NGKU4136
SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿
A303414A / 00801741073816¿ 10801741073813
Lot Number: NGKU1022
(416A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿
(714A/716A/718A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿
(914)SureStep" Foley Tray System
A304716A / 00801741104206 10801741104203
Lot Number: NGKT2496
A304714A / 00801741104268 10801741104265
Lot Number: NGKU2923
A304716A / 00801741104299 10801741104296
Lot Numbers:
NGKU1833
NGKU4729
A304718A / 00801741100376¿ 10801741100373
Lot Numbers:
NGKT3224
NGKU3971
SureStep" Foley Tray System Bardex¿ IC Complete Care¿
A319416A / 00801741100307¿ 10801741100304
Lot Number: NGKS1605
SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter
A319416AM / 00801741073861¿ 10801741073868
Lot Numbers:
NGKT2390
NGKT2410
NGKT3225
NGKT3319
NGKU0951
NGKU0977
SureStep" Foley Tray System Bardex¿ IC Complete Care¿
A319418A / 00801741100314¿ 10801741100311
Lot Number: NGKT2411
SureStep" Foley Tray System Bardex¿ IC Complete Care¿
A903316A / 00801741096600¿ 10801741096607
Lot Numbers:
NGKT3392
NGKU2020
****
SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care
A300414A / 00801741073755 10801741073752
Lot Number: NGKV3524
SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter
A319414AM / 00801741073854 10801741073851
Lot Number: NGKV3487
SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter
A319418AM / 00801741073878 10801741073875
Lot Number: NGKV4983
SureStep" Foley Tray System Bardex¿ IC Complete Care
A903318A / 00801741104657 10801741104654
Lot Number: NGKV2397
|
| FEI Number |
1018233
|
Recalling Firm/
Manufacturer |
C.R. Bard Inc
8195 Industrial Blvd Ne
Covington GA 30014-1497
|
| For Additional Information Contact |
770-784-6100 |
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Manufacturer Reason
for Recall | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | On 06/25/2026, an "URGENT Medical Device Recall" Letter was via regional courier services or other electronic means to inform customers that based on customer feedback, BD has identified that the CliniClean Pericare Wipes provided within Urinary Catheter Trays may be potentially contaminated with an unknown non-biological substance.
Customer are instructed to:
Do not use CliniClean Pericare Wipes contained within the affected products listed in Attachment 2. The CliniClean Pericare Wipes are the only impacted component within the tray and all remaining components can continue to be safely used. Users should source alternative, cleansing wipes for the impacted product lots listed in Attachment 2 and ensure they continue to follow their facility protocols for providing perineal care for patients with urinary catheters.
If affected CliniClean Pericare Wipes have been used without issue, no additional treatment or clinical follow up is required.
1. For affected lots, remove and destroy wipes within the product package at the point of use and do not use. Source alternative cleansing wipes for all impacted urinary catheter trays listed in Attachment 2.
2. Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Correction.
3. Post this notice in all locations where inventory of these trays are stored.
4. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may confirm your receipt of this notification.
For Questions - contact:
BD Medical Information Services:
Available 24/7 Select #2 when prompted 1-800-555-7422 or Email: medical.information@bd.com
BD Technical Support
1-844-8BD-LIFE (1-844-823-5433) Say Product Complaint when prompted M-F 8am - 5pm CT or Email: productcomplaints@bd.com |
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| Quantity in Commerce | 212580 |
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| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY. The countries of Bahrain, Canada, Costs Rica, Guatemala, Mexico, Saudi Arabia, and United Arab Emirates. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = MJC
510(K)s with Product Code = MJC
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