Recall Z-0815-2020 ยท GBO Catheter, Nephrostomy, General & Plastic Surgery
Cook Inc.
Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC
| Date | Dec 27, 2019 |
| Status | Terminated |
| Reason | Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly. |
| Root cause | Employee error |
| Action | On December 27, 2019, the firm sent Urgent Medical Device Recall letters to affected customers, advising them of the recalled products. Customers were asked to take the following actions: 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of r |
| Quantity | 1604 |
| Distribution | Nationwide domestic distribution. Foreign distribution to Australia, Belgium, Canada, China, Colombia, Denmark, France, Germany, Italy, Korea, Netherlands, New Zealand, Peru, Russia, Spain, Sweden, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.