Recall Z-3061-2011 ยท MJJ Cpb Check Valve, Retrograde Flow, In-Line
Alliant Enterprises LLC
Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035 QUANTITY: 25, DESCRIPTION: NONADJUSTABLE VENT VALVE, STERILE The TrueChoice Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent
| Date | Aug 23, 2011 (initiated Jul 21, 2011) |
| Status | Terminated |
| Reason | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. |
| Root cause | Other |
| Action | Alliant Healthcare sent an URGENT: MEDICAL DEVICE RECALL letter on 7/21/2011 and 7/25/2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately review the recall notification and quarantine any affected product. If product was further distributed, customers were to forward the letter with the Recall Return Response Form immediately to all affected locations and indicate which locations on the Recall Return Response Form. Customers were also instructed to discontinue use immediately, dispose of the affected pr |
| Quantity | 182 boxes of 25 |
| Distribution | Worldwide Distribution - USA including Michigan, Tennessee, New York, and California and the countries of Chile and Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001245 | 3T L. V. CONTROL VALVE 3t Medical Systems, LLC, Aug 15, 2001 |