FDA recall record

Winco Mfg TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair recall — FDA Z-0065-2017

Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.

Class IIclassification
Z-0065-2017official record ID
Oct 19, 2016report date

Recall record at a glance

Official recordZ-0065-2017
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmWinco Mfg., LLC
Report dateOct 19, 2016
Recall initiation dateJun 29, 2016
Quantity264 Stretcher Chairs
LocationOcala, FL, United States

Official product description

TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.

Why the product was recalled

Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.

Distribution information

Worldwide Distribution -- USA, including AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, VA, WA, WI, and Puerto Rico; and the countries of Canada, Australia, Italy, Panama, Switzerland and Taiwan.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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