Recall record at a glance
| Official record | Z-3115-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | C.R. Bard Inc. |
| Report date | Sep 16, 2026 |
| Recall initiation date | Jun 25, 2026 |
| Quantity | 283883 trays/kits |
| Location | Covington, GA, United States |
Official product description
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
Why the product was recalled
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
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