Z-3061-2011

Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035 QUANTITY: 25...

Name: Z-3061-2011 Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035 QUANTITY: 25...
Creator: Alliant Enterprises LLC
Published: 2011-07-21
License: https://open.fda.gov/license/

Surge Medical Sales, LLC (dba Surge Cardiovascular) / initiated 2011-07-21 / Terminated

FDA source

Alliant Enterprises LLC began a recall of Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035 QUANTITY: 25, DESCRIPTION: NONADJUSTABLE VENT VALVE, STERILE The TrueChoice... on 2011-07-21. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3061-2011
Status: Terminated
Initiated: 2011-07-21
Posted: 2011-08-23
Terminated: 2012-04-23
Recalling firm: Surge Medical Sales, LLC (dba Surge Cardiovascular)
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.
Product code: MJJ Cpb Check Valve, Retrograde Flow, In-Line
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 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 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
Product codes and lots: Lot # 2011-06-18 thru 2014-06-01

Product code MJJ

K001245Class II3T L. V. Control Valve3t Medical Systems, LLC / cleared 2001-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)