Z-0800-2016Class I

Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen...

Name: Z-0800-2016 Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen...
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 Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog... 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-0800-2016
Classification: Class I
Status: Terminated
Initiated: 2016-01-06
Posted: 2016-02-24
Terminated: 2017-08-23
Recalling firm: Cook Incorporated
Product: Single Lumen Pressure Monitoring 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: 2280
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 C-PMS-2502-15-3.5 C-PMS-2502-15-5.0 C-PMS-250-MONTES-A-092084 C-PMS-251 C-PMS-251J C-PMS-300 C-PMS-300-CHILDRENS-A-032988 C-PMS-300J C-PMS-301 C-PMS-301J C-PMS-301J-PKG C-PMS-400J Lots: 6028502 6034979 6083984 6194848 NS6014456 NS6014457 6148788 6254047 5906417 6160213 NS6064797 NS6014483 NS6175149 NS6184593 NS6187516 NS6014458 5889463 5898283 5922849 5941909 5964565 5976506 6021072 6028497 6143834 6160238 NS5933957 5828147 5941919 NS5932835 NS5932836 NS6050233 NS6072523 NS6108227 NS6130497 5803601 6034985 6075213 NS5833882 NS5892109 NS5892110 NS5919920 NS6021136 NS6054843 NS6072524 NS6075557 NS6082375 NS6108228 NS6148658 6067668

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0800-2016
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)