| Date Initiated by Firm |
January 06, 2016 |
| Date Posted |
February 24, 2016 |
| Recall Status1 |
Terminated 3 on August 23, 2017 |
| Recall Number |
Z-0801-2016 |
| Recall Event ID |
73056 |
| Product Classification |
Catheter, percutaneous - Product Code DQY
|
| Product |
Femoral Artery Pressure Monitoring 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. |
| Code Information |
RPN/Catalog number: C-NPMS-501J-15 C-NPMSY-501J-15 C-PMS-300-FA C-PMS-300J-FA C-PMS-301-FA C-PMS-301J-FA C-PMS-400-FA C-PMS-401-FA C-PMS-401J-FA C-PMSY-300-FA C-PMSY-300J-FA C-PMSY-400J-FA C-PMSY-401-FA Lots: 6054830 6054831 6072436 6078670 6081720 6083977 NS6054841 NS6054842 NS6075552 NS6082372 NS6082373 NS5833881 NS5881267 NS5881268 NS5892106 NS5892107 NS5892108 NS5914766 NS5922706 NS5928596 NS5932820 NS5932821 NS5967447 NS5967448 NS5967449 NS6014474 NS6014475 NS6014484 NS6014485 NS6042778 NS6042795 NS6042796 NS6050046 NS6063330 NS6063354 NS6075555 NS6100599 NS6100600 NS6108225 NS6124985 NS5888542 NS5928597 NS6028553 NS6042797 NS6090273 NS6090274 NS6100601 NS6130149 5800570 5860387 5891906 5980254 6003160 6062725 6143835 NS5830771 NS5866956 NS5866957 NS5881269 NS6014460 NS6042798 NS6050047 NS6075534 NS6075556 5895598 6129058 6148613 NS5932822 NS5932837 NS5994907 NS6130498 6067782 6139280 NS6042805 NS6130500 6049951 6137353 6139281 6034986 6049957 6067784 NS5833887 NS5866959 NS5881272 NS5881334 NS5881335 NS5919925 NS6047449 NS6054847 NS6054848 NS6072526 NS6072555 NS6082379 NS6090277 NS6105921 NS6124989 NS6130501 NS6148639 NS5866961 NS5866962 NS5892115 NS5922709 NS5932844 NS5974256 NS6031988 NS6031990 NS6042578 NS6050052 NS6050053 NS6031992 NS6031993 NS6130504 NS6137424 NS6054849 |
Recalling Firm/
Manufacturer |
Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
|
| For Additional Information Contact |
Cook Medical Customer Relations Departme
800-457-4500
|
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 |
1515 |
| 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.
|
