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U.S. Department of Health and Human Services

Class 2 Device Recall Timer, General Laboratory

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  Class 2 Device Recall Timer, General Laboratory see related information
Date Initiated by Firm June 23, 2015
Date Posted June 22, 2017
Recall Status1 Terminated 3 on September 01, 2017
Recall Number Z-2705-2017
Recall Event ID 77528
Product Classification Timer, general laboratory - Product Code JBS
Product O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 ---
INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
Code Information Lot #s: 079810; 078734, 081071, 140411, 141117, 140719, 140506, 130117 Expiration date: Jul.2016 
Recalling Firm/
Manufacturer		 O-Two Medical Technologies, Inc.
7575 Kimbel Street
Mississauga Canada
Manufacturer Reason
for Recall		 Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action O-Two Medical Technologies sent a Recall Notification on June 23, 2015, to all affected customers. The letter notified customers of the malfunctioning device, description, brand name, model/catalog number, target population, quantity, Lot Number, Shelf Life, hazard potential, and an image of labeling. The letter also provided instructions to customer for action and response. Customers were to return the affected product and O-Two will ship back the unaffected medical devices. Customers were instructed to acknowledge receipt of this recall notice by fax to 1-905-677-2035. For questions regarding this recall call 905-677-9410 or 1-800-387-3405.
Quantity in Commerce 4382 units (4082 units distributed USA)
Distribution Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland
Total Product Life Cycle TPLC 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.
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