Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW — Class II medical device recall Z-2365-2016
Terminated recall by Invacare Corporation, reported 2016-08-17, distributed in CA, CO, CT, FL, GA, IA, ID, IL…. The rear gradation scale was screen printed upside down on the flowmeter gauge.
| Recall number | Z-2365-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invacare Corporation, Elyria, OH, United States |
| Recall initiated | 2016-06-21 |
| Classified | 2016-08-08 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2017-02-07 |
| Distributed | 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 |
| Countries outside the US | CA, DE, NZ |
| Quantity | 395 units |
| Model numbers | 16CF024368, 16CF024369, 16CF024370, 16CF024371, 16CF024372, 16CF024373, 16CF024374, 16CF024375, 16CF024376, 16CF024377, 16CF024378, 16CF024379, 16CF024380, 16CF024381, 16CF024382, 16CF037743, IRCPF16, IRCPF16AW |
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 primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.
Reason for recall
The rear gradation scale was screen printed upside down on the flowmeter gauge.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2365-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.