Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediat
FDA device recall Z-2365-2016 · posted 2016-08-08 · Terminated
Recall details
- Recalling firm
- Invacare Corporation
- Reason for recall
- The rear gradation scale was screen printed upside down on the flowmeter gauge.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NFB
- Quantity affected
- 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.
- Date initiated
- 2016-06-21
- Date posted
- 2016-08-08
- Date terminated
- 2017-02-07
- Location
- Elyria, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS (K914488) | Invacare Corp. | 1992-09-15 |