Recall Z-3062-2011
Alliant Enterprises LLC · initiated July 21, 2011
Product
TruChoice Alliant Healthcare Products, REFERENCE# SSD-100EX, QUANTITY: 25, DESCRIPTION: TUBING W/ ONE WAY 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 retrograde flow and air to the heart.
Codes / lots: Lot # 2013-04-05 thru 2013-09-22
Reason for recall
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.
FDA-determined cause: Other
Action taken
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 product per their normal disposal protocol, and fax the Recall Return Response Form to Alliant Healthcare Products at 269-629-5770. Upon receipt of the Recall Return Response Form, a substitute vent valve (non-adjustable only) will be sent to their location for each affected product for which disposal has been properly documented in writing. For questions call 269-629-0300, ext 226.
Details
- Recall number
- Z-3062-2011
- Initiated
- July 21, 2011
- Posted by FDA
- August 23, 2011
- Terminated
- April 23, 2012
- Product code
- MJJ – Cpb Check Valve, Retrograde Flow, In-Line
- Quantity
- 16 Boxes of 25
- Distribution
- Worldwide Distribution - USA including Michigan, Tennessee, New York, and California and the countries of Chile and Korea
- Recalling firm
- Alliant Enterprises LLC, Richland, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3058-2011 | Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030 QUANTITY:…The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding… | 07/21/2011Terminated |
| Z-3059-2011 | Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030NS…The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding… | 07/21/2011Terminated |
| Z-3060-2011 | Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035NS…The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding… | 07/21/2011Terminated |
| Z-3061-2011 | Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035…The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding… | 07/21/2011Terminated |