ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems
FDA device recall Z-1898-2014 · posted 2014-06-25 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- 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.
- Action taken
- The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706.
- Root cause
- Process design
- Status
- Terminated
- Product code
- ERL
- Quantity affected
- 3
- Distribution
- 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. .
- Date initiated
- 2012-11-28
- Date posted
- 2014-06-25
- Date terminated
- 2014-08-07
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANSPACH MICROMAX SYSTEM (K965080) | The Anspach Effort, Inc. | 1997-01-10 |