Recall Z-1885-2011 ยท CAE Airway, Oropharyngeal, Anesthesiology
Microtek Medical Inc
MDI(R), S.A.L.T. Airway Device, Supraglottic Airway Laryngopharyngeal Tube, Intended for use with 6.5mm -9.00mm ET tubes, Including SALT(TM) airway, ET tube clamp, Latex-free securing strap, Tongue blade, Lubricating jelly, NON STERILE, REF 79-580, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, Manufactured in the Dominican Republic of U.S. Materials Supraglottic Airway Laryng
| Date | Jan 5, 2011 |
| Status | Terminated |
| Reason | Product contains Triad Lubricating Jelly which was recalled. |
| Root cause | Other |
| Action | The firm, Microtek Medical, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 17, 2011 to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and place any S.A.L.T. Airway Device (79-580) in quarantine; if they have distributed any of the product, they should identify their customers and notify them at once of this recall; complete and return the enclosed URGENT: MEDICAL DEVICE RECALL-RETURN RESPONSE form via fax to: (662)244-3011 or email: tom.bonner@ecolab.com, and |
| Quantity | 223 cases of 10 units |
| Distribution | Nationwide distribution: AZ, CA, CT, FL, IN, MS, NC, NH, PA, TX and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.