Recall Z-0126-2015— Bausch & Lomb Inc- Greenville Solutions Plant

Name: FDA recall Z-0126-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-25

Class II · Terminated

Class II FDA medical device recall by Bausch & Lomb Inc- Greenville Solutions Plant, initiated 2014-09-25, terminated 2015-06-12. It names one FDA 510(k) clearance: K083757. Product: Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc.. Reason: Product lot did not meet the specification for its disinfectants at the time of manufacture..

Recalling firm: Bausch & Lomb Inc- Greenville Solutions Plant
Classification: Class II
Status: Terminated
Initiated: 2014-09-25
Terminated: 2015-06-12
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K083757 — BPZ02 MULTIPURPOSE SOLUTIONBausch & Lomb, Inc.·cleared 2009-11-18

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

Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc.

Reason for recall

Product lot did not meet the specification for its disinfectants at the time of manufacture.

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