Invacare Perfecto 2 V Oxygen Concentrator Recalled for Defective Sieve Beds
Invacare is recalling 5,963 Perfecto 2 V Oxygen Concentrators because defective sieve beds allow dust to migrate, reducing oxygen concentration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device intended for patients with respiratory disorders where a defect reduces oxygen concentration. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Invacare Corporation is recalling 5,963 units of the Perfecto 2 V Oxygen Concentrator. The recall involves finished devices with serial numbers ranging from 14GF053772 to 14HF032124, as well as service part number 1165099. The defective sieve bed subassemblies were manufactured between July 31, 2014, and August 19, 2014.
The recall was initiated because a defective sieve bed subassembly allowed zeolite sieve dust to migrate into the valves of the manifold assembly and muffler. This migration causes a reduction in the oxygen concentration provided by the device. The device is intended to provide supplemental oxygen to patients with respiratory disorders.
The affected units were distributed nationwide to the following states: FL, NJ, GA, RI, PA, MI, CA, MA, IN, WA, CT, VA, NC, MO, AZ, CO, MS, WI, TN, NH, IL, LA, OK, HI, KY, NE, SC, TX, and IA. Consumers should contact Invacare Corporation for further instructions regarding the recall.
The recalled product
- 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 respira
- Manufacturer
- Invacare Corporation
- Affected units
- 5,963
Distribution
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