Z-0799-2016Class I

Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a...

Name: Z-0799-2016 Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a...
Creator: Cook Inc.
Published: 2016-01-06
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2016-01-06 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product... on 2016-01-06. FDA classified it as Class I and gives the reason as "A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting...". 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-0799-2016
Classification: Class I
Status: Terminated
Initiated: 2016-01-06
Posted: 2016-02-24
Terminated: 2017-08-23
Recalling firm: Cook Incorporated
Product: Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Product code: DQY Catheter, Percutaneous
Reason for recall: A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 1/6/2016, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Management/Recall Administration via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.
Quantity in commerce: 1341
Distribution: Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada
Product codes and lots: RPN/Catalog number: C-PMS-250-PED C-PMS-251J-PED C-PMS-300-CHILDRENS-032285 C-PMS-301J-PED C-PMS-301J-PED-BH C-PMS-301-PED C-PMSY-250 C-PMSY-251 C-PMSY-251J C-PMSY-300 C-PMSY-300J C-PMSY-300J-UT-A C-PMSY-300-PED C-PMSY-301J C-PMSY-301J-BH C-PMSY-301J-PED C-PMSY-301J-PED-OTP C-PMSY-400-HURLEY-022388 C-PUM-300J C-PUM-301 C-PUM-301J C-PUMY-301J Lots: NS6168054 NS6178118 NS6063352 NS5855441 5824486 5898058 5967405 6079119 NS5932737 NS6028554 NS6042799 NS5922707 NS5932811 NS6145002 5987014 NS6178099 NS6028540 NS5830758 NS5866960 NS5918174 NS5974263 NS6042577 NS6047450 NS6090278 NS6105922 NS6124990 NS5881337 NS5892116 NS6031991 5782006 5855241 NS5881336 NS5892113 NS5945282 6062729 NS5970950 NS6108255 NS6153173 5793198 5925744 6010406 6148800 NS5796483 NS5928602 NS6047451 NS5970942 NS5954223 5945120 NS5954224 5973354

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0799-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0799-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0800-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0801-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0802-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24

Product code DQY

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)