Z-1901-2014 Class II Terminated
FDA device recall Z-1901-2014 was initiated by The Anspach Effort, Inc. on Nov 28, 2012 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Aug 7, 2014). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 2, 2014
- Initiation Date
- Nov 28, 2012
- Termination Date
- Aug 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach Systems
Reason for Recall
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.
Distribution Pattern
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. .
Code Information
Part Number: 98-0048; Serial Number: 200073101.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1901-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026