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Class 2 Device Recall Pericardiocentesis Catheter Tray |
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Date Initiated by Firm |
April 09, 2019 |
Create Date |
June 04, 2019 |
Recall Status1 |
Terminated 3 on April 28, 2020 |
Recall Number |
Z-1724-2019 |
Recall Event ID |
82692 |
Product Classification |
Paracentesis tray - Product Code PYC
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Product |
Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030 |
Code Information |
Lot Number NS7639280 |
Recalling Firm/ Manufacturer |
Cook Inc. 750 N Daniels Way Bloomington IN 47404-9120
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For Additional Information Contact |
812-339-2235
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Manufacturer Reason for Recall |
Affected products may have been manufactured with the catheter distal end hole too small
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Action |
On April 9, 2019 Cook Medical issued URGENT MEDICAL DEVICE RECALL notices to customers via courier service.
Customers were advised to take the following Actions:
1. Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products.
2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit.
NOTE: Unaffected products that are returned will not be credited.
3. Complete and return 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 it via fax (812.339.7316) or by email to FieldActionsNA@CookMedical.com.
4. The 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 7:30 am and 5:00 pm (Eastern Time) or by email to CustomerRelationsNA@CookMedical.com. |
Quantity in Commerce |
2 kits |
Distribution |
Domestically: OH;
Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA,
AUSTRALIA, HONG KONG, INDIA & KOREA |
Total Product Life Cycle |
TPLC Device Report
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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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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