Recall Z-0577-2015— Invacare Corporation
Class II · Terminated
Class II FDA medical device recall by Invacare Corporation, initiated 2014-09-23, terminated 2015-06-18. It names one FDA 510(k) clearance: K020386. Product: Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.. Reason: It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration..
- Recalling firm
- Invacare Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-23
- Terminated
- 2015-06-18
- Firm location
- Elyria, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.
Reason for recall
It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.
Data sourced from openFDA. This site is unofficial and independent of the FDA.