Recall Z-0772-2018— Steris Corporation

Name: FDA recall Z-0772-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-28

Class II · Terminated

Class II FDA medical device recall by Steris Corporation, initiated 2017-09-28, terminated 2018-09-12. It names one FDA 510(k) clearance: K162413. Product: V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000). Reason: Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle..

Recalling firm: Steris Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-09-28
Terminated: 2018-09-12
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K162413 — AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization SystemSTERIS Corporation·cleared 2017-03-31

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

V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)

Reason for recall

Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.

Data sourced from openFDA. This site is unofficial and independent of the FDA.