Z-1349-2015Class II

Integral Wand W/tubing, Sterile, Ref 24185, Qty 24/Cs, Sterile Eo

Name: Z-1349-2015 Integral Wand W/tubing, Sterile, Ref 24185, Qty 24/Cs, Sterile Eo
Creator: Microtek Medical Inc
Published: 2015-03-10
License: https://open.fda.gov/license/

Microtek Medical LLC / initiated 2015-03-10 / Terminated / root cause: labeling and UDI

FDA source

Microtek Medical Inc began a recall of INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created... on 2015-03-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1349-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-10
Posted: 2015-03-27
Terminated: 2017-01-21
Recalling firm: Microtek Medical LLC
Product: INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO 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.
Product code: FYD Apparatus, Exhaust, Surgical
Reason for recall: 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 tag: labeling and UDI
FDA 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: [email protected] 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; [email protected].
Quantity in commerce: 9168 units
Distribution: US (nationwide) Distribution.
Product codes and lots: Lot Numbers: C10081, C10138, C10181, C10231, C10235, C11269, C11311, C12005, C12051, C12065, C12143, C12172, C12199, C12363, C13015, C13085, C13148, C13189, C13213, C13240, C13295, C13319, C13365, C14104, C14167

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1349-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1337-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27
Z-1338-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27
Z-1339-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27
Z-1340-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27
Z-1341-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27
Z-1342-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27
Z-1343-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27
Z-1344-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27
Z-1345-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27
Z-1346-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27
Z-1347-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27
Z-1348-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27
Z-1349-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27

Product code FYD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)