Recall Z-0803-2012 ยท BBT
SALTER LABS
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 Servic
| Date | Jan 26, 2012 (initiated Oct 21, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root 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 infor |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.