The Recall Desk
HighFDA (Devices)·Z-0780-2013·Announced 2013-02-13

Winco Medical Recliners Recalled for Fire Protection Non-Compliance

Winco Mfg. is recalling 95 medical recliners because their foam and vinyl do not meet California fire safety standards.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a fire safety hazard (TB 133 non-compliance) in a medical device. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Winco Mfg., LLC is recalling 95 units of the Designer Care Cliner 6700, 6704, and 6710 multi-position recliners. These medical devices, which feature a steel frame, are used in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, and infusion. The affected units were purchased between January 1, 2011, and August 20, 2012, and include a specific California TB 133 upgrade.

The recall is being conducted because the performance of the chemicals in the foam and vinyl is not consistent enough to meet the TB 133 fire protection mandate required by California and four other states. The devices were distributed nationwide, including in California, Florida, Illinois, Massachusetts, Maryland, Minnesota, New Mexico, New York, Ohio, Oklahoma, and Texas.

Winco Mfg., LLC is the recalling firm. Specific serial numbers for the affected units are listed in the official recall documentation. Users should contact the manufacturer for further instructions regarding the recall.

The recalled product

Product
Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Manufacturer
Winco Mfg., LLC
Category
Medical Device — Medical Furniture
Hazard
Affected units
95

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model 6700
  • 6704 and 6710. Serial numbers: 670A100027
  • 670A100028
  • 670A100323
  • 670100082
  • 670100083
  • 670A100101
  • 670A100021
  • 670A100324
  • 670A100325
  • 670A100284
  • 670A100242
  • 670100005
  • 670100124
  • 670100125
  • 670100181
  • 670100182
  • 670100183
  • 670100184
  • 670100185

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Winco Mfg., LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Winco Mfg., LLC

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Same hazard · fire

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