Recall Z-0482-2022— Ohio Medical Corporation

Name: FDA recall Z-0482-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-16

Class II · Ongoing

Class II FDA medical device recall by Ohio Medical Corporation, initiated 2021-11-16. It names one FDA 510(k) clearance: K933902. Product: Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.. Reason: Increase in premature device failures.

Recalling firm: Ohio Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-11-16
Firm location: Gurnee, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K933902 — MOBLVAC IIIAeros Instruments, Inc.·cleared 1994-05-20

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

Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.

Reason for recall

Increase in premature device failures

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