Recall Z-0177-2013— Ventlab Corporation

Name: FDA recall Z-0177-2013
Creator: U.S. Food and Drug Administration
Published: 2012-07-11

Class I · Terminated

Class I FDA medical device recall by Ventlab Corporation, initiated 2012-07-11, terminated 2013-06-30. It names one FDA 510(k) clearance: K012842. Product: Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.. Reason: Possible volume leakage through the inlet valve during compressions of the resuscitator bag..

Recalling firm: Ventlab Corporation
Classification: Class I
Status: Terminated
Initiated: 2012-07-11
Terminated: 2013-06-30
Firm location: Mocksville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K012842 — V*CARE MANUAL RESUSCITATORVentlab Corp.·cleared 2001-09-18

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

Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.

Reason for recall

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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