Z-1885-2011
MDI(R), S.A.L.T. Airway Device, Supraglottic Airway Laryngopharyngeal Tube, Intended for use with 6.5mm...
Microtek Medical LLC / initiated 2011-01-05 / Terminated
Microtek Medical Inc began a recall of 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... on . The reason FDA records is "Product contains Triad Lubricating Jelly which was recalled". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1885-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Microtek Medical LLC
- Product
- 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 Laryngopharyngeal Tube which can be used to facilitate blind, endotracheal intubation.
- Product code
- CAE Airway, Oropharyngeal, Anesthesiology
- Reason for recall
- Product contains Triad Lubricating Jelly which was recalled.
- FDA 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: [email protected], and return any unused product inventory to Microtek Medical. The firm will provide the customers with a replacement product as soon as product becomes available. If you have any questions in regards to this recall, please feel free to contact the V.P.-Regulator Affairs at 1-888-844-0988 or email: [email protected].
- Quantity in commerce
- 223 cases of 10 units
- Distribution
- Nationwide distribution: AZ, CA, CT, FL, IN, MS, NC, NH, PA, TX and WI.
- Product codes and lots
- Lot Numbers: C10259 and D103334
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