Z-2691-2011

Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical

Name: Z-2691-2011 Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical
Creator: Cook Endoscopy
Published: 2011-06-07
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2011-06-07 / Terminated / root cause: design

FDA source

Cook Endoscopy began a recall of 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... on 2011-06-07. The reason FDA records is "The disposable clip may not deploy after being positioned inside the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2691-2011
Status: Terminated
Initiated: 2011-06-07
Posted: 2011-06-28
Terminated: 2012-05-15
Recalling firm: Wilson-Cook Medical Inc.
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.
Product code: MND Ligator, Esophageal
Reason for recall: The disposable clip may not deploy after being positioned inside the patient.
Root cause tag: design
FDA 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 [email protected]. 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 [email protected] .
Quantity in commerce: 307 units
Distribution: (USA) Nationwide Distribution including the states of: CA, HI, MA, ME, NC and NY.
Product codes and lots: Lot numbers: W2965637, W2976210, W2978497, W2983595, W2986018, W2987394, W2987969, W2990400, and W2998860.

Product code MND

K023903Class IIWilson-Cook Endoscopic Clipping DeviceWilson-Cook Medical, Inc. / cleared 2003-02-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)