AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
FDA device recall Z-1064-2024 · posted 2024-02-25 · Open, Classified
Recall details
- Recalling firm
- Vyaire Medical
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- BTM
- Quantity affected
- 1,020,330 units
- Distribution
- Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
- Date initiated
- 2024-01-10
- Date posted
- 2024-02-25
- Location
- Mettawa, IL
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