FDA Medical Device Recalls (openFDA)
Cook Endoscopy: Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.
- Recall number
- Z-2691-2011
- Recalling firm
- Cook Endoscopy
- Product
- Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.
- Status
- Terminated
- Initiated
- 2011-06-07
- Posted
- 2011-06-28
- Terminated
- 2012-05-15
- Reason
- The disposable clip may not deploy after being positioned inside the patient.
- Root cause
- Device Design
- Action
- 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 .
- Quantity
- 307 units
- Distribution
- (USA) Nationwide Distribution including the states of: CA, HI, MA, ME, NC and NY.
- Lot, serial or model codes
- Lot numbers: W2965637, W2976210, W2978497, W2983595, W2986018, W2987394, W2987969, W2990400, and W2998860.
- 510(k) numbers
- ["K023903"]
- PMA numbers
- not on file
- Product code
- MND
- Firm FEI
- 1037905
- Firm city
- Winston Salem
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28