Nebulizer (adult elastic strap style aerosol mask 7' tube -… recallZ-0108-2012 · Salter Laboratories, Division of Regulatory Affairs · initiated Mar 25, 2011
Terminated All recalls posted in October 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Salter Laboratories, Division of Regulatory Affairs or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.
FDA root cause category: Equipment maintenance
What the company is doing
The firm, Salter Labs, called all their customers on March 25, 2011 and asked that they hold all affected product. In addition, the firm sent an "URGENT PRODUCT RECALL" letter dated April 4, 2011 and a follow-up letter dated April 7, 2011 via e-mail and certified mail to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory, return any affected lots listed, contact Salter Customer Service at 1-800-235-4203 to arrange for return of affected product and complete and return the Customer Reply Form via 661-854-6816 or toll free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.
Recall details
- Recall number
- Z-0108-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 25, 2011
- Posted by the FDA
- Oct 26, 2011
- Recalling firm
- Salter Laboratories, Division of Regulatory Affairs
- Quantity
- 9000 all varieties
- Product code
- CCQ
- FDA submissions
- K870027
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
Product description
Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.
Code information (models, lots, serial numbers)
Product code: 8924-7-50, Lot 022811
Other devices under the same FDA submission
1 device cleared under K870027 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Salter AIRE Elite SO-1774BESalter Labs · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)7 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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