| | Class 2 Device Recall Bard Foley/SureStep Foley Trays |  |
| Date Initiated by Firm | June 25, 2026 |
|---|
| Date Posted | September 04, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3115-2026 |
|---|
| Recall Event ID |
98840 |
| 510(K)Number | K040504 K070508 K070582 K984084 |
|---|
| Product Classification |
Catheter, Retention Type, Balloon - Product Code EZL
|
| Product | Products that contain the Pericare Wipes:
Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter
REF:
947314
947316
947318
UDI codes:
00801741024924 10801741024921
00801741024931 10801741024938
00801741024948 10801741024945
Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray
REF: 300416A
UDI code: 00801741024580 10801741024587
SureStep" Foley Tray System Lubri-Sil IC Complete Care
REF: A300416A
UDI code: 00801741073762 10801741073769
SureStep" Foley Tray System Lubri-Sil IC Complete Care
REF: A303416A
UDI code: 00801741073823 10801741073820
SureStep" Foley Tray System Lubri-Sil IC Complete Care
REF:
A307416A
A307418A
UDI codes:
00801741104381 10801741104388
00801741100505 10801741100502
SureStep" Foley Tray System Bard Silicone Foley Catheter Tray
REF: A897516
UDI code: 00801741073984 10801741073981
SureStep" Foley Tray System Bardex All- Silicone Foley Catheter Tray
REF: A902416
UDI code: 00801741074042 10801741074049
SureStep" Foley Tray System Bardex All- Silicone Foley Catheter Tray
REF: A902418
UDI code: 00801741074059 10801741074056
SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter
REF: A907316
UDI code: 00801741104749 10801741104746
SureStep" Foley Tray System with Bard Lubri-Sil Catheter
REF: A942210
UDI code: 00801741100567 10801741100564
SureStep" Foley Tray System with Bard Lubri-Sil Catheter
REF: A942212
UDI code: 00801741100536 10801741100533
SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter Tray
REF: A942214
UDI code: 00801741074103 10801741074100
SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter Tray
REF: A942216
UDI code: 00801741074110 10801741074117
SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter
REF: A947316
UDI code: 00801741074141 10801741074148
SureStep" Foley Tray System with Bard Lubri-Sil Catheter
REF: A942206
UDI code: 00801741100543 10801741100540
****
Lubri-Sil I.C. Complete Care Temp-Sensing Foley Catheter Tray and Urine Meter
REF: 319516AM
UDI code: 00801741024696 10801741024693
SureStep" Foley Tray System with Bard Lubri-Sil Temp Sensing Foley Catheter
REF: A119214M
UDI code: 00801741073670 10801741073677
REF: A119216M
UDI code: 00801741073687 10801741073684
SureStep" Foley Tray Lubri-Sil I.C. Complete Care Temp Sensing Catheter
REF: A300916A
UDI code: 00801741120862 10801741120869
SureStep" Foley Tray System Lubri-Sil IC Complete Care
REF: A319516A
UDI code: 00801741100338 10801741100335
SureStep" Foley Tray System Lubri-Sil IC Complete Care
REF: A319516AM
UDI code: 00801741073892 10801741073899
SureStep" Foley Tray Lubri-Sil I.C. Complete Care Temp Sensing Catheter
REF: A900916A
UDI code: 00801741121029 10801741121026
SureStep" Foley Tray System Lubri-Sil Temperature Sensing Foley Catheter
REF: A909216M
UDI code: 00801741104763 10801741104760
*****
Bard Urine Meter Foley Catheter Tray With Bard Lubri-Sil Catheter
REF 942208
UDI code: 00801741029370 10801741029377
Bard Urine Meter Foley Tray With Lubri-Sil All-Silicone Foley Catheter
REF: 942216
UDI code: 00801741024979 10801741024976
Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray and Urine Meter
REF: 303416A
UDI code: 00801741024726 10801741024723
SureStep" Foley Tray System with Bard Lubri-Sil Temp Sensing Foley Catheter
REF: A119218M
UDI code: 00801741073694 10801741073691
SureStep" Foley Tray System Lubri-Sil IC Complete Care
REF: A300418A
UDI code: 00801741073779 10801741073776
SureStep" Foley Tray System Lubri-Sil IC Complete Care
REF: A303418A
UDI code: 00801741073830 10801741073837
SureStep" Foley Tray System Lubri-Sil IC Complete Care
REF: A319514AM
UDI code: 00801741073885 10801741073882
SureStep" Foley Tray System with Bard Lubri-Sil Catheter
REF: A942208
UDI code: 00801741100550 10801741100557
SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter Tray
REF: A942218
UDI code: 00801741074127 10801741074124
SureStep" Foley Tray System Bard Lubri-Sil Foley |
|---|
| Code Information |
Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter
Catalog Numbers / UDI codes:
947314 / 00801741024924¿ 10801741024921
Lot Numbers:
NGKT2599
NGKU0115
947316 / 00801741024931¿ 10801741024938
Lot Numbers:
NGKU0162
NGKU2507
947318 / 00801741024948¿ 10801741024945
Lot Numbers:
NGKU2420
NGKU2865
Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray
300416A / 00801741024580 10801741024587
Lot Numbers:
NGKT1464
NGKU0129
SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿
A300416A / 00801741073762¿ 10801741073769
Lot Numbers:
NGKT3316
NGKU0946
NGKU0972
NGKU1747
NGKU1823
SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care
A303416A / 00801741073823 10801741073820
Lot Numbers:
NGKT2388
NGKT2495
NGKT3290
NGKT3303
NGKT3318
NGKU0949
NGKU0974
NGKU1749
NGKU2011
NGKU2036
NGKU2922
NGKV0359
NGKV0360
NGKV1433
NGKV1454
SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿
A307416A / 00801741104381 10801741104388
Lot Number: NGKS3764
A307418A / 00801741100505 10801741100502
Lot Number: NGKT2453
SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray
A897516 / 00801741073984 10801741073981
Lot Numbers:
NGKT3226
NGKU0841
NGKU0954
SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray
A902416 / 00801741074042¿ 10801741074049
Lot Numbers:
NGKU0843
NGKU2016
NGKU2049
NGKU2887
NGKU2929
NGKU3049
NGKU3975
NGKU4043
NGKU4716
SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray
A902418 / 00801741074059¿ 10801741074056
Lot Number: NGKU0956
SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter
A907316 / 00801741104749¿ 10801741104746
Lot Number: NGKU0855
SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter
A942210 / 00801741100567¿ 10801741100564
Lot Number: NGKT2458
SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter
A942212 / 00801741100536¿ 10801741100533
Lot Number: NGKT3373
SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray
A942214 / 00801741074103¿ 10801741074100
Lot Number: NGKT3232
SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray
A942216 / 00801741074110 10801741074117
Lot Numbers:
NGKT3366
NGKT3374
NGKT3375
NGKT3394
NGKT3395
NGKU0845
NGKU0856
NGKU0957
NGKU1003
NGKU1004
NGKU1757
NGKU1850
NGKU2021
NGKU2052
NGKU2890
SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter
A947316 / 00801741074141 10801741074148
Lot Numbers:
NGKT2396
NGKT2416
NGKT2460
NGKT3368
NGKT3377
NGKU0846
NGKU0857
NGKU0958
NGKU1758
NGKU1851
NGKU2022
NGKU4047
SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter
A942206 / 00801741100543 10801741100540
Lot Number: NGKT3364
*****
Lubri-Sil¿ I.C. Complete Care¿ Temp-Sensing Foley Catheter Tray and Urine Meter 319516AM / 00801741024696¿ 10801741024693
Lot Number: NGKU1994
SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter
A119214M / 00801741073670¿ 10801741073677
Lot Number: NGKV0292
A119216M / 00801741073687 10801741073684
Lot Numbers:
NGKS3759
NGKT1887
NGKT2383
NGKT2404
NGKT3314
NGKU0971
SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter
A300916A / 00801741120862¿ 10801741120869
Lot Number: NGKS4948
SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿
A319516A / 00801741100338 10801741100335
Lot Number: NGKT1899
SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿
A319516AM / 00801741073892 10801741073899
Lot Numbers:
NGKS4850
NGKT0702
NGKT0768
NGKT1863
NGKT2391
NGKT2412
NGKT2455
NGKT3305
NGKU0978
NGKU1025
NGKU2925
SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter
A900916A / 00801741121029¿ 10801741121026
Lot Number: NGKS4959
SureStep" Foley Tray System Lubri-Sil¿ Temperature Sensing Foley Catheter
A909216M / 00801741104763¿ 10801741104760
Lot Number: NGKT2394
*****
Bard¿ Urine Meter Foley Catheter Tray With Bard¿ Lubri-Sil¿ Catheter
942208 / 00801741029370 10801741029377
Lot Number: NGKW2677
Bard¿ Urine Meter Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter
942216 / 00801741024979 10801741024976
Lot Numbers:
NGKW2822
NGKW2751
Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray and Urine Meter
303416A / 00801741024726 10801741024723
Lot Numbers:
NGKW3769
NGKW0682
SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter
A119218M / 00801741073694 10801741073691
Lot Number: NGKW0605
SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿
A300418A / 00801741073779 10801741073776
Lot Number: NGKX3768
SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿
A303418A / 00801741073830 10801741073837
Lot Numbers:
NGKW1796
NGKV1455
SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿
A319514AM / 00801741073885 10801741073882
Lot Numbers:
NGKW2687
NGKV2393
SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter
A942208 / 00801741100550 10801741100557
Lot Number: NGKV3560
SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray
A942218 / 00801741074127 10801741074124
Lot Number: NGKX4530
SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter
A947314 / 00801741074134 10801741074131
Lot Numbers:
NGKW0616
NGKV4999
NGKV3635
NGKV2289
|
| 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 |
|---|
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 |
|---|
| 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 |
|---|
| Quantity in Commerce | 283883 trays/kits |
|---|
| 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. |
|---|
| 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 = EZL
510(K)s with Product Code = EZL
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