—#178600

Product

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

FDA product code: GBO — Catheter, Nephrostomy, General & Plastic Surgery
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 9799196 9909433 9909435 NS9915808 9796032 9797075 9803175 9806067 9903048 9904465 9904469 9908750 9912303 9916724 9785599 9785601 9791159 9796027 9813313 9824161 9825417 9828101 9828889 9830401 9830764 9833563 9836323 9839119 9844952 9846005 9846008 9913052 9915805 9791163X 9792493X NS9813314 NS9828892 NS9834712

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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 receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-12-27
Terminated: 2020-11-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178600. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.