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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2752-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2753-2018 | Class II | Terminated | Voluntary: Firm initiated |
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