Recall Z-0982-03 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Ventlab Corporation
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 functionin
| Date | Jul 8, 2003 (initiated Apr 15, 2003) |
| Status | Terminated |
| Reason | Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product. |
| Root cause | Other |
| Action | Consignee was notified by fax on 3/15/2003. All product on hand were returned to Ventlab. |
| Quantity | 9 cases (10 units per case) |
| Distribution | The product was distributed to one consignee in CA. The cases were returned to the recalling firm. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.