CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is suppl
FDA device recall Z-2243-2014 · posted 2014-08-27 · Terminated
Recall details
- Recalling firm
- Cook Inc.
- Reason for recall
- This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.
- Action taken
- Cook Medical sent an Urgent Medical Device Recall letter dated July 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the attached list of affected products and lot numbers shipped to their account, and quarantine any affected product that remains unused. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. Complete the attached Recalled Product Reply Form and return to Cook Medical either with the product or separately. Customers were asked to report any Adverse Event to Cook Medical Customer Relations at 800-457-4500 or 1-812-339-2235.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MMX
- Quantity affected
- 696 devices total distribution (671 nationwide)
- Distribution
- Worldwide Distribution - USA including AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TX, UT, VA, WA, WI, WV and Internatio
- Date initiated
- 2014-07-17
- Date posted
- 2014-08-27
- Date terminated
- 2015-06-16
- Location
- Bloomington, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOURSNARE VASCULAR RETRIEVAL SNARE (K112185) | Cook, Inc. | 2011-11-02 |