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Terminated

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.

FDA Recall Z-0982-03 · Posted 2003-07-08

Recalling FirmVentlab Corporation
Recall StatusTerminated
Product CodeBTM
Date Initiated2003-04-15
Date Terminated2003-08-07
Product Quantity9 cases (10 units per case)

Reason for Recall

Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product.

Firm Action

Consignee was notified by fax on 3/15/2003. All product on hand were returned to Ventlab.

Root Cause

Other

Distribution Pattern

The product was distributed to one consignee in CA. The cases were returned to the recalling firm.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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