Z-0982-03

V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series...

Name: Z-0982-03 V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series...
Creator: Ventlab Corporation
Published: 2003-04-15
License: https://open.fda.gov/license/

Salter Labs / initiated 2003-04-15 / Terminated

FDA source

Ventlab Corporation began a recall of V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic... on 2003-04-15. The reason FDA records is "Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0982-03
Status: Terminated
Initiated: 2003-04-15
Posted: 2003-07-08
Terminated: 2003-08-07
Recalling firm: Salter Labs
Product: V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the patient valve several times while squeezing the bag body. Retest the resuscitator for proper functioning. VentLab Corporation, 2934 Highway 601N, Mockville, NC 27028.
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product.
FDA root cause: Other
Action: Consignee was notified by fax on 3/15/2003. All product on hand were returned to Ventlab.
Quantity in commerce: 9 cases (10 units per case)
Distribution: The product was distributed to one consignee in CA. The cases were returned to the recalling firm.
Product codes and lots: Lot numbers 3332838D, 333238D5; Product Codes: VN3100OCP, VN3100MC, VN3100OCP-B, VN3100MCP-2 and VN3100OCB

Product code BTM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)