ClearanceBrief
Recall Z-2752-2018 ยท FNL Bed, Ac-Powered Adjustable Hospital

Handicare Usa Inc

Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.

DateNov 3, 2017
StatusTerminated
ReasonPremature strap wear and breakage at maximum weight conditions (625 lbs.).
Root causeNonconforming Material/Component
ActionHandiCare USA sent an Urgent notification letter dated November 3, 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were informed new units will be sent to replace the affected units identified at no charge. For questions contact your Customer Service
Quantity716
DistributionWorldwide Distribution - US Nationwide in the states of AK, CA, CT, DE, GA, IA, IL, KY, LA, MA, ME, MI, MN, MO, NE, NV, NY, OH, OR, PA, RI, TN, TX, WI, and Puerto Rico and the countries of Canada and Australia,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.