Recall Z-0824-2019— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2018-12-26, terminated 2020-06-16. It names 2 FDA 510(k) clearances: K091136, K082435. Product: ATLAS Loading Car. Reason: The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-26
- Terminated
- 2020-06-16
- 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
ATLAS Loading Car
Reason for recall
The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side.
Data sourced from openFDA. This site is unofficial and independent of the FDA.