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U.S. Department of Health and Human Services

Class 1 Device Recall Salter Labs Bubble humidifier

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  Class 1 Device Recall Salter Labs Bubble humidifier see related information
Date Initiated by Firm October 21, 2011
Date Posted January 26, 2012
Recall Status1 Terminated 3 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 2		 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.
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