Recall Z-1371-05 ยท MOD Accessory To Continuous Ventilator (Respirator)
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.
| Date | Aug 16, 2005 (initiated Jun 8, 2005) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010401 | TRI-PLEX ADAPTER The Medical Device Group, Inc., Oct 30, 2002 |