Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2365-2016·Announced 2016-08-17

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: Invacare Corporation
Category: Medical Device — Oxygen Flowmeter
Hazard: mis-labeling
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

Distributed in 30 states:

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.

See all 2 products in this recall →

Same manufacturer · Invacare Corporation

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Same hazard · mis labeling