FDAFDA · Food and drugs·Recall number Z-0815-2020
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
Published January 22, 2020 · Recall initiated: December 27, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Inc.
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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