The Anspach Effort, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1894-2014)
See the recall detail below. You can also see other recalls from the same firm in 2014.
ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
Class II
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Part Number: 98-0034; Serial Numbers: C25302189205, C26302224202, C25302189204, C25302067902, C26302224204, C27302202503, C28302328702, C25302189204, C25302127005, C25302067902, C26302224202, C25302141301, C25302189201, C28302328705, C25302127003, C25302141304.
Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .
Voluntary: Firm initiated