FDA Medical Device Recalls (openFDA)
Cook, Inc.: Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038'' end hole; Reorder # MWCE-38-20-20.
- Recall number
- Z-0368-06
- Recalling firm
- Cook, Inc.
- Product
- Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038'' end hole; Reorder # MWCE-38-20-20.
- Status
- Terminated
- Initiated
- 2005-09-26
- Posted
- 2006-01-10
- Terminated
- 2006-01-10
- Reason
- The coil is 20 centimeters in length, but the label states the length is 20 millimeters.
- Root cause
- Other
- Action
- Consignees were notified via telephone and recall letter dated September 26, 2005.
- Quantity
- 242
- Distribution
- Delaware, New York and Pennsylvania.
- Lot, serial or model codes
- Lots F512190X, F612598, F712671, F782158, F1015070, F1246233, F1296872, F1306174, F1324630, F1333380, F1345472, F1395273 and F1479165.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KRD
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- 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