Z-1371-05

Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100 (MD-04002). Sterile. Single...

Name: Z-1371-05 Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100 (MD-04002). Sterile. Single...
Creator: Medical Device Group Inc.
Published: 2005-06-08
License: https://open.fda.gov/license/

The Medical Device Group, Inc. / initiated 2005-06-08 / Terminated

FDA source

Medical Device Group Inc. began a recall of Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100 (MD-04002). Sterile. Single Use on 2005-06-08. The reason FDA records is "Device separation presenting a choking hazard". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1371-05
Status: Terminated
Initiated: 2005-06-08
Posted: 2005-08-16
Terminated: 2012-04-06
Recalling firm: The 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.
Product code: MOD Accessory To Continuous Ventilator (Respirator)
Reason for recall: Device separation presenting a choking hazard.
FDA 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 in commerce: 2,282
Distribution: Nationwide, Brasil and Canada
Product codes and lots: Lot 2005001

Product code MOD

K010401Class IITri-Plex AdapterThe Medical Device Group, Inc. / cleared 2002-10-30

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)