Recall Z-2365-2016 ยท NFB Conserver, Oxygen
Invacare Corporation
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.
| Date | Aug 8, 2016 (initiated Jun 21, 2016) |
| Status | Terminated |
| Reason | The rear gradation scale was screen printed upside down on the flowmeter gauge. |
| Root cause | Process control |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914488 | MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS Invacare Corp., Sep 15, 1992 |