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U.S. Department of Health and Human Services

Class 1 Device Recall Cook Medical

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  Class 1 Device Recall Cook Medical see related information
Date Initiated by Firm January 06, 2016
Date Posted February 24, 2016
Recall Status1 Terminated 3 on August 23, 2017
Recall Number Z-0800-2016
Recall Event ID 73056
Product Classification Catheter, percutaneous - Product Code DQY
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.
Code Information 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 
Recalling Firm/
Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Departme
Manufacturer 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.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.