Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
Recall
- Recall Number
- Z-1565-2020
- Event Number
- 85187
- Firm
- Cook Inc.
- FEI Number
- 1820334
- Product Code
- GBX
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- March 6, 2020
- Terminated
- December 18, 2020
- Address
- 750 N Daniels Way, Bloomington, IN, 47404-9120
Description
Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
The printed expiration dates are incorrect.
An Urgent Medical Device Recall notification letter dated 3/6/2020 was distributed to customers. Actions to be Taken by the Customer 1.Examine inventory immediately to determine if you have affected product(s) and quarantine anyaffected product that remains unused. Immediately cease all distribution and use of this product. 2.Return the affected product(s) to Cook Medical with a copy of the Acknowledgement andReceipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form forreturn instructions. Note: Unaffected products that are returned will not be credited. 3.Please complete the Acknowledgement and Receipt Form within 5 business days of receivingthis letter. Even if you do not have affected product(s) on hand, you must still complete theAcknowledgement and Receipt Form and return via fax (812.339.7316) or email([email protected]). 4.This notice must be shared with appropriate personnel, including down to the user level, withinyour organization or with any organization where the potentially affected devices have beentransferred. 5.Immediately report adverse events to Cook Medical Customer Relations by phone at800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (EasternTime), or by email to: [email protected].
The products were distributed to the following US states: CO, DE, MD, MN, NC, NV, and WV. The products were distributed to the following foreign countries: Canada.
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