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COOK INCORPORATED · Model G15540 · UDI-DI 00827002155404
FAP
Prescription
10
510(k) clearances
55
Adverse events
6
Recalls
9
Facilities
Description
Urodynamic Balloon Catheter Triple Lumen
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-08 | Spes Medica | The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. |
| 2021-04-08 | Spes Medica | The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. |
| 2018-03-15 | Teleflex Medical Europe Ltd | These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause All |
| 2005-12-13 | Sandhill Scientific, Inc | The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains a latex- free symbol. |
| 2005-12-13 | Sandhill Scientific, Inc | The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains a latex- free symbol. |
| 2005-12-13 | Sandhill Scientific, Inc | Labeling does not indicate that the product contains latex. |
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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.