Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set

FDA device recall Z-1870-2017 · posted 2017-04-19 · Terminated

Recall details

Recalling firm

Cook Inc.

Reason for recall

Product may overheat, melt, and burn patient.

Action taken

On 3/7/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. 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. Action To Be Taken: 1. Examine inventory immediately to determine if you have affected products and quarantine affected products. 2. Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. 3. Even if you do not have affected products on hand, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email to (fieldactionsna@cookmedical.com). 4. Complete and return the Acknowledgement and Receipt Form attached to this letter within 30 days. 5. 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 via customerrelationsna@cookmedical.com. This notice must be shared with appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. Should you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

Root cause

Device Design

Status

Terminated

Product code

FCS

Quantity affected

19756

Distribution

The devices have been distributed within the United States and the following countries: Bahamas, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finl

Date initiated

2017-03-07

Date posted

2017-04-19

Date terminated

2018-10-16

Location

Bloomington, IN

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