Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for end

FDA device recall Z-2691-2011 · posted 2011-06-28 · Terminated

Recall details

Recalling firm

Cook Endoscopy

Reason for recall

The disposable clip may not deploy after being positioned inside the patient.

Action taken

Wilson-Cook Medical, Inc. (Cook Endoscopy) sent an "URGENT: PRODUCT RECALL" notice dated June 7, 2011 and a "PRODUCT RECALL EFFECTIVENESS SURVEY' dated June 21, 2011 to all affected consignees. The notice described the product, problem, and actions to be taken. Medical users were instructed to quarantine any affected products and return to Cook Medical. The distributors were instructed to contact their customers and coordinate the return of the affected products to Cook Medical. The recalled notice and survey should be completed and returned to Cook Medical via fax to 812-339-7316 or scanned and emailed to CustomerRelationsNA@cookmedical.com. If you have any questions regarding this matter, please contact the Customer Relations Department at toll free-1-800-457-4500, press 4 then enter extension 2146 or by email at CustomerRelationsNA@cookmedical.com .

Root cause

Device Design

Status

Terminated

Product code

MND

Quantity affected

307 units

Distribution

(USA) Nationwide Distribution including the states of: CA, HI, MA, ME, NC and NY.

Date initiated

2011-06-07

Date posted

2011-06-28

Date terminated

2012-05-15

Location

Winston Salem, NC

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