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Class 2 Device Recall Handicare P600 Series Patient Lift |
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| Date Initiated by Firm |
November 03, 2017 |
| Create Date |
August 20, 2018 |
| Recall Status1 |
Terminated 3 on July 10, 2020 |
| Recall Number |
Z-2753-2018 |
| Recall Event ID |
80556 |
| Product Classification |
Bed, ac-powered adjustable hospital - Product Code FNL
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| Product |
Handicare P600 Series Patient Lift
Product Usage:
A device used to lift and transport a patient from one place to another.
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| Code Information |
Device Model; 303090 and 303093 |
Recalling Firm/
Manufacturer |
Handicare Usa Inc
10888 Metro Ct
Maryland Heights MO 63043-2413
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| For Additional Information Contact |
866-891-6502
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Manufacturer Reason
for Recall |
Premature strap wear and breakage at maximum weight conditions (625 lbs.).
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FDA Determined
Cause 2 |
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 |
4 |
| 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, |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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