Z-0173-2013Class I

V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation...

Name: Z-0173-2013 V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation...
Creator: Ventlab Corporation
Published: 2012-07-11
License: https://open.fda.gov/license/

Salter Labs / initiated 2012-07-11 / Terminated / root cause: design

FDA source

Ventlab Corporation began a recall of V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable... on 2012-07-11. FDA classified it as Class I and gives the reason as "Possible volume leakage through the inlet valve during compressions of the resuscitator bag". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0173-2013
Classification: Class I
Status: Terminated
Initiated: 2012-07-11
Posted: 2012-11-01
Terminated: 2013-06-30
Recalling firm: Salter Labs
Product: V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Root cause tag: design
FDA root cause: Component design/selection
Action: VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to [email protected]. For questions regarding this recall call 336-753-5000.
Quantity in commerce: 14,602 total for all units
Distribution: Nationwide Distribution including IL, OH, NY and TN.
Product codes and lots: Product List 071012, Product Codes: VN3200MB, Lot #102032, VN3100MB-2, Lot #102033; VN3100MBP, Lot #102046, 102182; VN3100MB-PW2, Lot 3102050; VN3100OB, Lot #102150.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0173-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0170-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01
Z-0171-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01
Z-0172-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01
Z-0173-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01
Z-0174-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01
Z-0175-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01
Z-0176-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01
Z-0177-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01
Z-0178-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01
Z-0179-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01
Z-0180-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01
Z-0181-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01

Product code BTM

K012842Class IIV*care Manual ResuscitatorVentlab Corp. / cleared 2001-09-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)