ClearanceBrief
Recall Z-1520-2015 ยท ION Exerciser, Non-Measuring

Amtryke LLC

AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle.

DateApr 24, 2015 (initiated Mar 27, 2015)
StatusTerminated
ReasonProduct is being recalled due to complaints of cracked frames.
Root causeUnder Investigation by firm
ActionConsignees were notified via letter on 03/27/2015.
Quantity53 units
DistributionUS nationwide distribution to AL, CA, FL, HI, IL, KY, KS, LA, MI, NY, OK, OR, PA, SC, TX, VA, VT and WV.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.