Recall Z-0478-2014— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2013-10-18, terminated 2014-05-13. It names 2 FDA 510(k) clearances: K091136, K082435. Product: AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.. Reason: The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-18
- Terminated
- 2014-05-13
- Firm location
- Mentor, OH, United States
510(k) clearances named in this recall
2 on FDA's record- K091136 — AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200
- K082435 — AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.
Reason for recall
The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.
Data sourced from openFDA. This site is unofficial and independent of the FDA.