FDA Medical Device Recalls (openFDA)
Alliant Enterprises LLC: 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.
- Recall number
- Z-3062-2011
- Recalling firm
- Alliant Enterprises LLC
- 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.
- Status
- Terminated
- Initiated
- 2011-07-21
- Posted
- 2011-08-23
- Terminated
- 2012-04-23
- 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 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
- 16 Boxes of 25
- Distribution
- Worldwide Distribution - USA including Michigan, Tennessee, New York, and California and the countries of Chile and Korea
- Lot, serial or model codes
- Lot # 2013-04-05 thru 2013-09-22
- 510(k) numbers
- ["K001245"]
- PMA numbers
- not on file
- Product code
- MJJ
- Firm FEI
- 3004986960
- Firm city
- Richland
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28