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

FDA device recall Z-3061-2011 · posted 2011-08-23 · Terminated

Recall details

Recalling firm

Alliant Enterprises LLC

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.

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.

Root cause

Other

Status

Terminated

Product code

MJJ

Quantity affected

182 boxes of 25

Distribution

Worldwide Distribution - USA including Michigan, Tennessee, New York, and California and the countries of Chile and Korea

Date initiated

2011-07-21

Date posted

2011-08-23

Date terminated

2012-04-23

Location

Richland, MI

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