Class 1 Device Recall Salter Labs Bubble humidifier

• Date Initiated by Firm: October 21, 2011
• Date Posted: January 26, 2012
• Recall Status: Terminated on February 15, 2012
• Recall Number: Z-0803-2012
• Recall Event ID: 60270
• Product Classification: Humidifier, respiratory gas, (direct patient interface) - Product Code BBT
• Product: 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.
• Code Information: 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; Humidifier lot numbers: 091911 and 092611.
• Recalling Firm/ Manufacturer: SALTER LABS; 100 Sycamore Rd; Arvin CA 93203-2300
• For Additional Information Contact: Michael Shoup; 661-854-6871
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 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

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.