FDA Medical Device Recalls (openFDA)
Microtek Medical Inc: VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
- Recall number
- Z-1344-2015
- Recalling firm
- Microtek Medical Inc
- Product
- VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
- Status
- Terminated
- Initiated
- 2015-03-10
- Posted
- 2015-03-27
- Terminated
- 2017-01-21
- Reason
- This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
- Root cause
- Error in labeling
- Action
- The firm, Ecolab - Microtek Medical, sent an "Urgent: Recall - Mislabeled Product Immediate Action Required" letter dated March 2015 to its US customers on 03/10/2015 via letter and email. The letter describes product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and promptly quarantine the lot(s) listed; complete and return the enclosed Recall Response Form via fax to Quality Assurance Manager, Ecolab-Microtek Medical at (662) 244-3011 or email to: recall@ecolab.com RE: Recall - Mislabeled Product ASAP, and if you have further distributed the products subject to this recall, please notify your customers at once. Upon receipt of the completed response forms, Ecolab-Microtek Medical will issue a return material authorization (RMA) and ask that you return any unopened product listed above to Ecolab-Microtek Medical at the address listed in the attached form. If you have any questions in regard to this recall, please contact Customer Service by phone at 1-800-824-3027 or email; customerservice@microtekmed.com.
- Quantity
- 30796 units
- Distribution
- US (nationwide) Distribution.
- Lot, serial or model codes
- Lot Numbers: C9344, C10091, C10158, C10214, C10221, C10257, C10264, C10298, C10342, C11060, C11104, C11118, C11136, C11180, C11216, C11237, C11290, C11313, C11334, C12060, C12096, C12180, C12206, C12235, C12243, C12334, C12355, C13008, C13032, C13042, C13053, C13067, C13128, C13179, C13212, C13248, C13281, C13303, C13317, C13338, C14036, C14057, C14121, C14140, C14169, C14183, C14197, C14233
- 510(k) numbers
- ["K001082","K910515"]
- PMA numbers
- not on file
- Product code
- FYD
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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