Z-1604-2016 Class II Terminated
FDA device recall Z-1604-2016 was initiated by Ferno-Washington Inc on March 10, 2016 and is designated Class II. Reason for recall: On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. The firm investigated and determined its supplier had l… The recall status is terminated (terminated August 23, 2016). Affected quantity: 270.
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2016
- Initiation Date
- March 10, 2016
- Termination Date
- August 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 270
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall. and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR and AUSTRALIA..