Recall Z-0586-2020— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2019-10-22, terminated 2020-06-09. It names 3 FDA 510(k) clearances: K112055, K091731, K082435. Product: Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam. Reason: The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward.
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-22
- Terminated
- 2020-06-09
- Firm location
- Mentor, OH, United States
510(k) clearances named in this recall
3 on FDA's record- K112055 — AMSCO CHIMERON MEDIUM STEAM STERILIZER
- K091731 — AMSCO EVOLUTION MEDIUM STEAM STERILIZER
- 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
Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
Reason for recall
The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward
Data sourced from openFDA. This site is unofficial and independent of the FDA.