Recall Z-1057-2024 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Vyaire Medical
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
| Date | Feb 25, 2024 (initiated Jan 10, 2024) |
| Status | Open, Classified |
| Reason | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017. |
| Root cause | Process control |
| Action | Vyaire issued an URGENT: Customer notification Letter to its consignees on 01/10/2024 via letter delivered by UPS Next Day Air. The notice explained the problem, complaints received, and requested the consignee discard or destroy all affected devices. If the consignee further distributed the product, they were directed to forward a copy of the notice to those parties. |
| Quantity | 106,656 units |
| Distribution | Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.