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U.S. Department of Health and Human Services

Class 2 Device Recall S.A.L.T. Airway Device

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  Class 2 Device Recall S.A.L.T. Airway Device see related information
Date Initiated by Firm January 05, 2011
Create Date June 26, 2015
Recall Status1 Terminated 3 on June 20, 2011
Recall Number Z-1885-2011
Recall Event ID 57743
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
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.
Code Information Lot Numbers: C10259 and D103334
Recalling Firm/
Manufacturer		 Microtek Medical Inc
602 N Lehmberg Rd
Columbus MS 39702-4406
For Additional Information Contact Elizabeth Jolly
888-844-0988
Manufacturer Reason
for Recall		 Product contains Triad Lubricating Jelly which was recalled.
FDA Determined
Cause 2		 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 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: Tom.bonner@ecolab.com.
Quantity in Commerce 223 cases of 10 units
Distribution Nationwide distribution: AZ, CA, CT, FL, IN, MS, NC, NH, PA, TX and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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