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Terminated

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

FDA Recall Z-1371-05 · Posted 2005-08-16

Recalling FirmMedical Device Group Inc.
Recall StatusTerminated
Product CodeMOD
Date Initiated2005-06-08
Date Terminated2012-04-06
Product Quantity2,282

Reason for Recall

Device separation presenting a choking hazard.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide, Brasil and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010401TRI-PLEX ADAPTERThe Medical Device Group, Inc. · 2002-10-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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