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U.S. Department of Health and Human Services

Class 2 Device Recall Southmedic Oxygen Masks with EtCO2 sampling line part number OM21258, 25 masks per case.

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 Class 2 Device Recall Southmedic Oxygen Masks with EtCO2 sampling line part number OM21258, 25 masks per case.see related information
Date Initiated by FirmOctober 17, 2017
Date PostedJanuary 25, 2018
Recall Status1 Terminated 3 on March 29, 2024
Recall NumberZ-1288-2018
Recall Event ID 78568
510(K)NumberK014211 
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
ProductSouthmedic 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.
Code Information 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)
Recalling Firm/
Manufacturer		 Southmedic, Inc.
50 Alliance Blvd
Barrie Canada
For Additional Information Contact
800-463-7146
Manufacturer Reason
for Recall		Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
FDA Determined
Cause 2		Device Design
ActionCustomers 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
Quantity in Commerce8,871 cases (25 masks per case) total
DistributionUS Distribution to the state of California, and Internationally to Canada and Sweden
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CCK
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