device · product 1 of 1
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S
- Recall number
- Z-2462-2025
- Initiated
- June 18, 2025
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- C.R. Bard Inc
- Quantity
- 175,158
App-derived interpretation
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Official device-enrichment evidence · Sourced
Process design
Inspect official wording and provenance
Reason for recall
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Code information
Catalog/UDI-DI/Lot(Expiration): 119314/00801741039843, 10801741039840/NGJS3588(31/03/2029), NGKQ2500(21/12/2029), NGKQ0170(30/11/2029), NGJW2499(31/08/2029), NGJT1284 (31/03/2029), NGKQ2492(31/12/2029), NGKP3152(31/12/2029), NGJX0215(31/07/2029). A319514A/00801741100321, 10801741100328/NGJN0498(31/01/2026), NGJW3127(30/04/2027) 29000J14/21200BZY00110000/MYJX0683(28/05/2027), MYJP0751(28/02/2027), MYJR1984(28/04/2027), MYJQ0070(28/04/2027), MYJS6278(28/04/2027), MYJR3026(28/04/2027), MYJT3766(28/04/2027), MYJY6197(28/06/2027), MYJX2833(28/06/2027), MYJQ4022(28/04/2027), MYJT3764(28/04/2027), MYJZ0962(28/06/2027), MYJS4679(28/04/2027), MYJX0686(28/06/2027), MYJV4359(28/03/2027), MYJS3597(28/04/2027), MYJW1900(28/04/2027), MYJT3765(28/04/2027), MYJY1245(28/06/2027), MYJY1242(28/06/2027), MYJY1248(28/06/2027). 29030J14/21200BZY00110000/MYJX2846(28/06/2027), MYJP2013(28/02/2027), MYJT1017(28/04/2027), MYJW1906(28/04/2027), MYJT4535(28/07/2027), MYJP4407(28/04/2027), MYJS1895(28/04/2027), MYJW1904(28/04/2027), MYJV4102(28/03/2027), MYJX2836(28/05/2027), MYJZ4526(28/06/2027), MYJT3468(28/04/2027), MYJP2012(28/02/2027), MYJV4099(28/03/2027), MYJZ0964(28/06/2027), MYJQ0071(28/04/2027), MYJS6279(28/04/2027), MYJY4511(28/06/2027), MYJQ4024(28/04/2027), MYJZ0963(28/06/2027), MYJT1018(28/04/2027), MYJR3027(28/04/2027), MYJS3599(28/04/2027), MYJQ4023(28/04/2027), MYJR3083(28/04/2027), MYJY4512(28/06/2027), MYJQ0073(28/04/2027), MYJS1893(28/04/2027), MYJN2580(28/01/2027), MYJU2705(28/08/2027), MYJZ4527(28/06/2027), MYJS1894(28/04/2027), MYJV4103(28/03/2027), MYJR3059(28/04/2027), MYJU0772(28/08/2027), MYJV4101(28/03/2027), MYJY4513(28/06/2027), MYJQ0072(28/04/2027), MYJU3846(28/03/2027), MYJU3847(28/05/2027), MYJX2841(28/06/2027), MYJX2840(28/05/2027), MYJX2839(28/05/2027), MYJY4510(28/06/2027), MYJY4509(28/06/2027), MYJV4100(28/06/2027), MYJU3848(28/06/2027). 29000J14S/21200BZY00110000/MYJY1249(28/06/2027), MYJY0937(28/05/2027), MYJW1903(28/03/2027). 29030J14S/21200BZY00110000/MYJU0773(28/08/2027)
Distribution pattern
Worldwide - US Nationwide distribution in the states of IA, PA, AR, OR, MN, IN, WV, OK, AL, MD, HI, GA, AZ, MA, FL, CA and the countries of Japan.