Recall Z-2365-2016
Invacare Corporation · initiated June 21, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial numbers for Model IRCPF16AW: 16CF024370, 16CF024373, 16CF024376, 16CF024379, 16CF024382,16CF024368,16CF024369, 16CF024371,16CF024372, 16CF024374,16CF024375, 16CF024377,16CF024378, 16CF024380,16CF024381, 16CF037743.
Reason for recall
The rear gradation scale was screen printed upside down on the flowmeter gauge.
FDA-determined cause: Process control
Action taken
lnvacare Corporation sent an Urgent Medical Device Recall letter dated June 27, 2016, to all affected consignees with return receipt to notify them of the recall. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees with questions were instructed to call 877-413-6008.
Details
- Recall number
- Z-2365-2016
- Initiated
- June 21, 2016
- Posted by FDA
- August 8, 2016
- Terminated
- February 7, 2017
- Product code
- NFB – Conserver, Oxygen
- Quantity
- 395 units
- Distribution
- Worldwide Distribution - US to 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.
- Recalling firm
- Invacare Corporation, Elyria, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2364-2016 Class II | lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton.…The rear gradation scale was screen printed upside down on the flowmeter gauge. | 06/21/2016Terminated |