FDA Medical Device Recalls (openFDA)
Medical Device Group Inc.: Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100 (MD-04002). Sterile. Single Use.
- Recall number
- Z-1371-05
- Recalling firm
- Medical Device Group Inc.
- Product
- Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100 (MD-04002). Sterile. Single Use.
- Status
- Terminated
- Initiated
- 2005-06-08
- Posted
- 2005-08-16
- Terminated
- 2012-04-06
- Reason
- Device separation presenting a choking hazard.
- Root cause
- Other
- Action
- Distributors were contacted by telephone on June 8, 2005, distributors were requested to return product. Letters were also sent by mail with proof of reciept on June 10, 2005. Firm reports that all customers have been notified.
- Quantity
- 2,282
- Distribution
- Nationwide, Brasil and Canada
- Lot, serial or model codes
- Lot 2005001
- 510(k) numbers
- ["K010401"]
- PMA numbers
- not on file
- Product code
- MOD
- Firm FEI
- 3004500043
- Firm city
- Poway
- Firm state
- CA
- 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