Z-0815-2020Class II

Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6...

Name: Z-0815-2020 Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6...
Creator: Cook Inc.
Published: 2019-12-27
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2019-12-27 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of 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 on 2019-12-27. FDA classified it as Class II and gives the reason as "Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0815-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-27
Posted: 2020-01-16
Terminated: 2020-11-23
Recalling firm: Cook Incorporated
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
Product code: GBO Catheter, Nephrostomy, General & Plastic Surgery
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.
Root cause tag: manufacturing process
FDA 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 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 ([email protected]). 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: [email protected].
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0815-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0815-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-16

Product code GBO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)