PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 22, 2020 Initiated: December 27, 2019 #Z-0815-2020

Product Description

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

Reason for Recall

Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.

Details

Recalling Firm
Cook Inc.
Units Affected
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.
Location
Bloomington, IN

Frequently Asked Questions

What product was recalled?
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. Recalled by Cook Inc.. Units affected: 1604.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 22, 2020. Severity: Moderate. Recall number: Z-0815-2020.