V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile
FDA device recall Z-0982-03 · posted 2003-07-08 · Terminated
Recall details
- Recalling firm
- Ventlab Corporation
- Reason for recall
- Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product.
- Action taken
- Consignee was notified by fax on 3/15/2003. All product on hand were returned to Ventlab.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTM
- Quantity affected
- 9 cases (10 units per case)
- Distribution
- The product was distributed to one consignee in CA. The cases were returned to the recalling firm.
- Date initiated
- 2003-04-15
- Date posted
- 2003-07-08
- Date terminated
- 2003-08-07
- Location
- Mocksville, NC
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