Medical Devices
Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy
Recall Class: Class I
Date Recall Initiated: October 21, 2011
Product: Salter Labs 7600 Bubble Humidifier, 350cc volume with 6PSI safety valve. Affected humidifiers were distributed from September 21, 2011 to October 17, 2011.
Model numbers: 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that contain 7600 bubble humidifiers. Lot numbers: 091911 and 092611.
Special order patient kits were sold under the following brand names:
- Salter Labs
- AdvaCare
- Allcare Medical
- Memorial Home Services
- Therapy Support Inc.
- Mendo-Lake Home Respiratory Services
- MedAssurance Inc.
- Abundant Home Care
Use: The 7600 Bubble Humidifier is used for supplemental oxygen therapy. The humidifier is used to provide additional humidity to supplemental oxygen therapy. This product is a single-use device used in health care facilities and home health care.
Recalling Firm:
Salter Labs
100 Sycamore Road
Arvin, California 93203
Reason for Recall: A manufacturing defect was discovered internally which indicated that, in certain lots of the 7600 Bubble Humidifiers, the humidifier lids failed to pop off at the intended pressure. Also, when the pop-off does occur, the brass slug does not always reseat to the appropriate position. When the slug fails to reseat properly, the humidifier can leak.
For conscious adult patients and in hospital settings with well trained personnel, the leak characteristic of this defect would be obvious. However, for an unconscious, critically ill patient, or for an infant, or child patient, or a home care patient, the leaking may not be obvious to the patient or to the caregiver in a home care situation.
A humidifier leak will potentially interrupt the flow of supplemental oxygen to the patient. Hypoxemia may develop resulting in death or serious adverse health consequences. The firm has received a total of 0 reports of incidents in which the device has apparently malfunctioned, including 0 injuries and 0 deaths.
Public Contact: Affected customers with questions may contact Salter Labs Customer Service at 800-421-0024 or 800-235-4203.
FDA District: San Francisco
FDA Comments: Salter Labs contacted its direct customers on October 21, 2011 to inform them of the recall. Customers were provided with a Recall Customer Reply Form to be returned to the company by FAX.
Salter Labs instructed consumers who have the affected bubble humidifiers to:
- Examine its inventory of the recalled product. Remove and quarantine all affected products.
- Complete the Recall Customer Reply form and return it by Fax to 1-800-628-4690 or 661-854-6816.
- Direct customers of Salter Labs who have distributed the affected bubble humidifiers to their own customers should contact their customers and follow the procedures outlined in steps 1 and 2.
Salter Labs Customer Service Representatives are available to assist in returning affected products to the company and completing the Recall Customer Reply Form. The firm has reported that 95% of the product has been accounted for and returned to its quarantine area. The firm will inspect and destroy the returned products.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, by telephone, or by FAX.
