Salter Labs Bubble humidifier, with 6 PSI safety valve, 350cc, Latex Free; Single Patient use; used with supplemental ox

FDA device recall Z-0803-2012 · posted 2012-01-26 · Terminated

Recall details

Recalling firm

SALTER LABS

Reason for recall

A manufacturing defect was discovered internally which indicates that in a small number of humidifier lids, the pop-off may not occur at the appropriate pressure and can result in a leak.

Action taken

Salter Labs contacted each customer directly on October 21, 2011 to inform them of the recall. Upon speaking to the direct customers, Salter Labs also provided a Recall Customer Reply Form for each direct customer to complete and return by fax to 661-854-6816 or 1-800-628-4690. Customers were instructed to immediately examine their inventory of the recalled product, remove and quarantine all affected products, indicate if product would be returned and asked if product was further distributed. If so, the second page of the response form was to be completed and returned. Customers were informed that a representatives from Salter Labs can assist, if needed, in returning all affected products to Salter and completing the attached forms. Salter's direct customers are instructed to contact their customers, should the product have undergone further distribution.

Root cause

Process control

Status

Terminated

Product code

BBT

Quantity affected

6,060 units ( 163 cases)

Distribution

Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, IL, MO, NJ, OH, OK, TX and the country of: Italy

Date initiated

2011-10-21

Date posted

2012-01-26

Date terminated

2012-02-15

Location

Arvin, CA