Recall Z-0109-2012 ยท BYG Mask, Oxygen
Salter Laboratories, Division of Regulatory Affairs
Mask adult, oxygen, medium concentration, elastic strap style w. 7' tube (Linde) 50/cs Mask, adult, oxygen, high concentration, non-rebreathing, elastic strap style w/ 7' tube and safety vent - 50/cs; Mask adult, oxygen, high concentration, non-rebreathing, w/7' tube w/out safety vent - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.
| Date | Oct 26, 2011 (initiated Mar 25, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Equipment maintenance |
| Action | 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 661-854-68 |
| Quantity | 2800 all varieties |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.