Invacare Pediatric Flowmeter Recalled Due to Upside-Down Rear Scale
Invacare is recalling 395 Precise Rx Pediatric Flowmeters because the rear gradation scale was printed upside down, which may confuse users.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a labeling/printing error on a secondary scale, which is a minor labeling error or low-risk issue, fitting the Moderate severity criteria.
Plain-English summary
Invacare Corporation is recalling 395 units of the Invacare Precise Rx Pediatric Flowmeter, Model Number IRCPF16 AW. The recall is due to a manufacturing defect where the rear gradation scale on the flowmeter gauge was screen printed upside down.
The flowmeter is designed to adapt to Invacare Concentrators for low-flow oxygen usage. The device features a scale printed on both the front and back sides. The front scale is the primary source for monitoring oxygen flow, while the rear scale serves as an aide for monitoring. The upside-down printing on the rear scale may cause confusion for users relying on that specific view.
The affected units were distributed worldwide, including to specific states in the US (CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MS, MT, NC, NE, NJ, NM, NY, OH, PA, SC, TN, TX, UT, VA, WA) and internationally to Canada, Germany, and New Zealand. Consumers should check their flowmeter serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the pri
- Manufacturer
- Invacare Corporation
- Hazard
- Affected units
- 395
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Serial numbers for Model IRCPF16AW: 16CF024370
- 16CF024373
- 16CF024376
- 16CF024379
- 16CF024382
- 16CF024368
- 16CF024369
- 16CF024371
- 16CF024372
- 16CF024374
- 16CF024375
- 16CF024377
- 16CF024378
- 16CF024380
- 16CF024381
- 16CF037743.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Invacare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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