Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2752-2018Class II

Handicare C Series Patient Lift

Handicare USA, Inc. / initiated 2017-11-03 / Terminated / root cause: manufacturing process

Handicare Usa Inc began a recall of Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another on . FDA classified it as Class II and gives the reason as "Premature strap wear and breakage at maximum weight conditions (625 lbs.)". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2752-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Handicare USA, Inc.
Product
Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
Premature strap wear and breakage at maximum weight conditions (625 lbs.).
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
HandiCare 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
Quantity in commerce
716
Distribution
Worldwide 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,
Product codes and lots
Device Model; 323100, 323102, 323117, 323118, 323120, 323137, 323149, 323150, 323215, 323225, 323237, 323240, 323400, 323417, 323450, 323600, 323602, 323700, 323750, 323840, 323851, 323917, 323117V, and 323150V

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2752-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2752-2018Class IITerminatedVoluntary: Firm initiated
Z-2753-2018Class IITerminatedVoluntary: Firm initiated