Date Initiated by Firm | July 21, 2011 |
Date Posted | August 23, 2011 |
Recall Status1 |
Terminated 3 on April 23, 2012 |
Recall Number | Z-3061-2011 |
Recall Event ID |
59524 |
510(K)Number | K001245 |
Product Classification |
Cpb check valve, retrograde flow, in-line - Product Code MJJ
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Product | 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 retrograde flow and air to the heart. |
Code Information |
Lot # 2011-06-18 thru 2014-06-01 |
Recalling Firm/ Manufacturer |
Alliant Enterprises LLC 8850 M 89 Richland MI 49083-8558
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For Additional Information Contact | Mrs. Rebecca Hudson 269-629-0300 Ext. 226 |
Manufacturer 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 2 | 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 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. |
Quantity in Commerce | 182 boxes of 25 |
Distribution | Worldwide Distribution - USA including Michigan, Tennessee, New York, and California and the countries of Chile and Korea |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MJJ
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