Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF
FDA device recall Z-2462-2025 · posted 2025-08-28 · Open, Classified
Recall details
- Recalling firm
- C.R. Bard Inc
- 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.
- Action taken
- On 6/18/2025, recall notices were mailed or emailed to Recall Coordinators, Directors of Nursing, Purchasing, Risk Management, and distributors who were informed the following: The affected product was distributed from 07 March 2024 to 14 May 2025. - If affected product is currently indwelling and draining urine appropriately, the catheter does not need to be removed. - For affected product currently not in use, quarantine, and dispose of unused product and source alternative product. - Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Recall (Correction). - If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product. - Complete and return the attached Customer Response Form via Email BDRC26@bd.com Report any complaints experienced with the use of this product to the firm via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) say "Product Complaints" when prompted Mon-Fri 8:00am and 5:00pm CT, Email: productcomplaints@bd.com Firm's Medical Information Services: 1-800-555-7422, medical.information@bd.com
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- EZL
- Quantity affected
- 175,158
- Distribution
- 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.
- Date initiated
- 2025-06-18
- Date posted
- 2025-08-28
- Location
- Covington, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS (K070582) | C.R. Bard, Inc. | 2007-12-07 |