FDA Medical Device Recalls (openFDA)
MedAmicus,Inc: Medamicus FlowGuard 16 FR Valved Peelable Introducer Kit, Catalog Number 10532-011
- Recall number
- Z-0962-03
- Recalling firm
- MedAmicus,Inc
- Product
- Medamicus FlowGuard 16 FR Valved Peelable Introducer Kit, Catalog Number 10532-011
- Status
- Terminated
- Initiated
- 2003-06-06
- Posted
- 2003-07-02
- Terminated
- 2004-07-02
- Reason
- Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Root cause
- Other
- Action
- The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products.
- Quantity
- 20 units
- Distribution
- The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
- Lot, serial or model codes
- Lot Number W23152
- 510(k) numbers
- ["K021044"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 2183787
- Firm city
- Plymouth
- Firm state
- MN
- 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