Salter Labs Bubble humidifier, with 6 PSI safety valve, 350cc, Latex Free; Single Patient use; used with supplemental oxygen therapy. Model Numbers 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that contain 7600 humidifiers. Patient kits have brand names of Salter Labs, AdvaCare; Allcare Medical; Memorial Home Services; Therapy Support Inc; Mendo-Lake Home Respiratory Services; MedAssurance Inc.; Abundant Home Care. Product Usage: Humidifier - single patient use. used with supplemental oxygen therapy.
Recall
- Recall Number
- Z-0803-2012
- Event Number
- 60270
- Firm
- SALTER LABS
- FEI Number
- 1314417
- Product Code
- BBT
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- October 21, 2011
- Posted
- January 26, 2012
- Terminated
- February 15, 2012
- Address
- 100 Sycamore Rd, Arvin, CA, 93203-2300
Description
Salter Labs Bubble humidifier, with 6 PSI safety valve, 350cc, Latex Free; Single Patient use; used with supplemental oxygen therapy. Model Numbers 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that contain 7600 humidifiers. Patient kits have brand names of Salter Labs, AdvaCare; Allcare Medical; Memorial Home Services; Therapy Support Inc; Mendo-Lake Home Respiratory Services; MedAssurance Inc.; Abundant Home Care. Product Usage: Humidifier - single patient use. used with supplemental oxygen therapy.
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.
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.
Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, IL, MO, NJ, OH, OK, TX and the country of: Italy
6,060 units ( 163 cases)