AMSCO Evolution steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry
FDA device recall Z-0478-2014 · posted 2013-12-11 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.
- Action taken
- Steris sent an Urgent Voluntary Field Correction Notice letter dated October 18, 2013 to their customers. The letter identified the affected product, problem, and actions to be taken. The letter informed customers that a Steris Service Representative will contact affected facility to arrange for Steris to upgrade the Transfer Carriage(s). For questions contact Steris Field Service Dispatch at 1-800-333-8828.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FLE
- Quantity affected
- 936 units
- Distribution
- Worldwide Distribution - USA Nationwide in the states of: AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MI, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD
- Date initiated
- 2013-10-18
- Date posted
- 2013-12-11
- Date terminated
- 2014-05-13
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 (K091136) | STERIS Corporation | 2009-06-29 |
| AMSCO EVOLUTION MEDIUM STEAM STERILIZER (K082435) | STERIS Corporation | 2008-12-30 |