Recall Z-1592-2018— Cook Inc.

Name: FDA recall Z-1592-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-31

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2018-01-31, terminated 2020-04-17. It names one FDA 510(k) clearance: K062475. Product: StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006. Reason: The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-01-31
Terminated: 2020-04-17
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K062475 — LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MMThe Laryngeal Mask Co., Ltd.·cleared 2007-05-09

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

StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006

Reason for recall

The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.

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