FDAFDA · Food and drugs·Recall number Z-1896-2014
ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems
Published July 2, 2014 · Recall initiated: November 28, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Anspach Effort, Inc.
- Distributor
- 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. .
- Lot
- Part Number: 98-0037; Serial Number: 2000940.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.