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Bard® Add-A-Foley Tray
C. R. Bard, Inc. · Model 399400A · UDI-DI 00801741024290
KNX
Prescription
10
510(k) clearances
2,118
Adverse events
19
Recalls
125
Facilities
Description
Bard® Add-A-Foley Tray
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-04 | Cardinal Health 200, LLC | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2019-01-14 | Teleflex Medical | The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label |
| 2019-01-14 | Teleflex Medical | The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label informa |
| 2017-06-02 | C.R. Bard, Inc. | Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier. |
| 2016-07-11 | C.R. Bard, Inc. | The product contained a latex catheter instead of a silicone catheter. |
| 2016-06-29 | C.R. Bard, Inc. | Labeling problem |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.