Reported Oct 11, 2017 · Terminated
IVEA Product Part Number 16100 Model 500A
Firefly Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Firefly Medical, Inc. · 320 E Vine Dr Ste 312 · Fort Collins, CO · 80524-2332
Is this the product you have?
- IVEA Product Part Number 16100 Model 500A
- Lot codes and dates
828 of 828 codes
Serial Numbers - 100201100251100297100343100390100438100487100666100586100202100252100298100344100391100439100488100667100587100204100253100299100345100392100440100489100507100588100205100254100300100346100393100441100490100508100592100206100255100301100347100394100442100491100509100593100207100256100302100348100395100443100492100510100594100208100257100303100349100396100444
- Amount recalled
- 570 units
Why it was recalled
The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.
This product could cause temporary or reversible health problems — stop using it.
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