Recall Z-3115-2026
- Recall number
- Z-3115-2026
- Event number
- 98840
- Firm
- C.R. Bard Inc
- Firm FEI
- 1018233
- Product code
- EZL
- Status
- Open, Classified
- Initiated
- 2026-06-25
- Posted
- 2026-09-04
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K040504, K070508, K070582, K984084, K212151, K021939, K130908, K091767, K971643, K771860, K930344, K181814, K972184, K973076, K240057, K182635, K071423, K181616, K192034, K182463, K013174, K974419, K905042, K031748, K190060, K232469, K810691, K013172, K082815, K262056
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: 008017410...
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.