Z-2397-2015Class II
Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis...
Champion Mfg, Inc. / initiated 2015-04-02 / Terminated / root cause: manufacturing process
Winco Mfg., LLC began a recall of Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities on . FDA classified it as Class II and gives the reason as "Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2397-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Champion Mfg, Inc.
- Product
- Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
- Product code
- INN Chair, Adjustable, Mechanical
- Reason for recall
- Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Winco sent a field correction letter dated April 2, 2015, to all affected customers The letter identified the product, the problem, and the action to be taken by the customer. Winco instructed customers that they will replace the recliners at no charge to the customer. Winco will provide detailed instructions for the replacement of the seats by their facility staff. Winco will extend the remaining warranty on the entire chair for a period of 6 months as compensation. If product was further distributed customers were instructed to notify those customers of the field correction. Customers were asked to complete and return the enclosed field correction response form as soon as possible. Customers with questions should contact Customer Care Monday-Friday 8:30 AM-5:00 PM EST at 800-237-3377 or email [email protected]. For questions regarding this recall call 352-854-2929.
- Quantity in commerce
- 3 chairs
- Distribution
- Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
- Product codes and lots
- Model Number: 6570, Serial Numbers: 657A102238, 658A102236 and 657A102237
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2391-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2392-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2393-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2394-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2395-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2396-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2397-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2398-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2399-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2400-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2401-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2402-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2403-2015 | Class II | Terminated | Voluntary: Firm initiated |
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