FDA Device recall Z-2365-2016
Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton by Invacare, citing the rear gradation scale was screen printed upside down on the flowmeter gauge.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2365-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-21 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Invacare |
| Distribution | 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 |
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
The rear gradation scale was screen printed upside down on the flowmeter gauge.
Identifiers
| code_info | Serial numbers for Model IRCPF16AW: 16CF024370, 16CF024373, 16CF024376, 16CF024379, 16CF024382,16CF024368,16CF02436…Serial numbers for Model IRCPF16AW: 16CF024370, 16CF024373, 16CF024376, 16CF024379, 16CF024382,16CF024368,16CF024369, 16CF024371,16CF024372, 16CF024374,16CF024375, 16CF024377,16CF024378, 16CF024380,16CF024381, 16CF037743. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2365-2016%22
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