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FDA Medical Device Recalls (openFDA)

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 Laryngopharyngeal Tube which can be used to facilitate blind, endotracheal intubation.

Recall number
Z-1885-2011
Recalling firm
Microtek Medical Inc
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.
Status
Terminated
Initiated
2011-01-05
Posted
not on file
Terminated
2011-06-20
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 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
223 cases of 10 units
Distribution
Nationwide distribution: AZ, CA, CT, FL, IN, MS, NC, NH, PA, TX and WI.
Lot, serial or model codes
Lot Numbers: C10259 and D103334
510(k) numbers
not on file
PMA numbers
not on file
Product code
CAE
Firm FEI
1043582
Firm city
Columbus
Firm state
MS
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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