Recall record at a glance
| Official record | Z-2705-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | O-Two Medical Technologies, Inc. |
| Report date | Jul 19, 2017 |
| Recall initiation date | Jun 23, 2015 |
| Quantity | 4382 units (4082 units distributed USA) |
| Location | Mississauga, Canada |
Official product description
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
Why the product was recalled
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.
Distribution information
Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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