Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1520-2015Class II

AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle

Amtryke LLC / initiated 2015-03-27 / Terminated

Amtryke LLC began a recall of AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle on . FDA classified it as Class II and gives the reason as "Product is being recalled due to complaints of cracked frames". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1520-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Amtryke LLC
Product
AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle.
Product code
ION Exerciser, Non-Measuring
Reason for recall
Product is being recalled due to complaints of cracked frames.
FDA root cause
Under Investigation by firm
Action
Consignees were notified via letter on 03/27/2015.
Quantity in commerce
53 units
Distribution
US nationwide distribution to AL, CA, FL, HI, IL, KY, KS, LA, MI, NY, OK, OR, PA, SC, TX, VA, VT and WV.
Product codes and lots
Model: 1424, System number 50-HC-1424, Batch number 2-1301 and GM-0314.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1520-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1520-2015Class IITerminatedVoluntary: Firm initiated