Recall Z-3239-2017— Firefly Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Firefly Medical, Inc., initiated 2017-08-24, terminated 2019-11-01. FDA's recall record names no specific 510(k) clearance for this event. Product: IVEA Product Part Number 16100 Model 500A. Reason: 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..
- Recalling firm
- Firefly Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-24
- Terminated
- 2019-11-01
- Firm location
- Fort Collins, CO, United States
Product description
IVEA Product Part Number 16100 Model 500A
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.