Z-0767-2017 Class II Terminated
FDA device recall Z-0767-2017 was initiated by Firefly Medical, Inc. on November 1, 2016 and is designated Class II. Reason for recall: The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble. The recall status is terminated (terminated August 1, 2017). Affected quantity: 239.
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2016
- Initiation Date
- November 1, 2016
- Termination Date
- August 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 239
Product Description
IVEA 500A Intended for Med-Surg patient care.
Reason for Recall
The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.
Distribution Pattern
Worldwide Distribution -- USA and Canada.
Code Information
Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.