Z-0065-2017 Class II Terminated
FDA device recall Z-0065-2017 was initiated by Winco Mfg., LLC on June 29, 2016 and is designated Class II. Reason for recall: Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. The recall status is terminated (terminated September 27, 2017). Affected quantity: 264 Stretcher Chairs.
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2016
- Initiation Date
- June 29, 2016
- Termination Date
- September 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 264 Stretcher Chairs
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.
Reason for Recall
Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Distribution Pattern
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.
Code Information
All identified serial numbers.