Recall Z-1288-2018
Southmedic, Inc. · initiated October 17, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
Codes / lots: Part No. (Lot No.); OM-2125-8 (W40056, W40161, W40162, W40317, W40556, W40645, W40668); OK-2125-8 (W37602, W37898, W39852, W40051, W40863); OK-2125-8SLM (W36957, W39164, W39695, W41454); OM-2125-14 (W36512, W38338); OM-2125-14SLM (W35876, W39251, W40873); OM-2125-8 (W36432, W36433, W37099, W37605, W37741, W37742, W37743, W37998, W38477, W38641, W39023, W39850, W40056, W40161, W40162, W40317, W40556, W40645, W40668); OM-2125-8SLM (W36956, W37342, W37488, W37899, W38700, W38905, W39252, W39545, W39546); OM-2325-8(W38340); OP-2125-14 (W37273, W39697); OP-2125-8 (W37031, W38005, W38190, W39027, W39851); OP-2125-8SLM (W37901, W38692, W39253, W41447)
Reason for recall
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
FDA-determined cause: Device Design
Action taken
Customers were notified via letter on October 17, 2017. Instructions included checking inventory for affected devices and quarantining any found, complete and return the Voluntary Recall Notification Confirmation Form, and arrange for the return of any affected products. On February 14, 2018, the recall was expanded and customers were notified. Instructions were the same as the original notification, but updated the Part/Lot information. For further questions, please call 1 (800) 463-7146
Details
- Recall number
- Z-1288-2018
- Initiated
- October 17, 2017
- Posted by FDA
- January 25, 2018
- Terminated
- March 29, 2024
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Quantity
- 8,871 cases (25 masks per case) total
- Distribution
- US Distribution to the state of California, and Internationally to Canada and Sweden
- Recalling firm
- Southmedic, Inc., Barrie