CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report

Vacuum Tubing 7/8" X 6' X, With Tubing Extender, Sterile recalled

Microtek Medical is recalling Vacuum Tubing 7/8" X 6' X, With Tubing Extender, Sterile, distributed nationwide in the US. The recall was initiated on 10 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: C10147, C10166, C10169, C10174, C10196, C10201, C10207, C10210, C10236, C10298, C11067, C11089, C11108, C11194, C11208, C11238, C11271, C11311, C11362, C12009, C12020, C12032, C12034,C12058, C12081, C12118, C12165, C12187, C12214, C12228, C12303, C12333, C13014, C13050, C13072, C13214, C13282, C13291, C13322, C14090, C14209

Quantity recalled56904 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1345-2015
FDA event ID: 70721
Recalling firm: Microtek Medical, Columbus, MS
Classification: Class II
Status: Terminated
Recall initiated: 10 Mar 2015
FDA classified: 27 Mar 2015
Reported: 8 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Surgical Instruments

Timeline

10 Mar 2015	Recall initiated by company
27 Mar 2015	Classified by FDA	+17 days
8 Apr 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, 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.

Where it was distributed

US (nationwide) Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Numbers: C10147, C10166, C10169, C10174, C10196, C10201, C10207, C10210, C10236, C10298, C11067, C11089, C11108, C11194, C11208, C11238, C11271, C11311, C11362, C12009, C12020, C12032, C12034,C12058, C12081, C12118, C12165, C12187, C12214, C12228, C12303, C12333, C13014, C13050, C13072, C13214, C13282, C13291, C13322, C14090, C14209

Where was it sold?

US (nationwide) Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

12 other products · FDA event 70721

This product is part of a recall event; the main page for the event is Vacuum Tubing 7/8" X 6' X recalled by Microtek Medical.

Reported	Class	Recall	Company	Reason	Where
8 Apr 2015	CLASS II	Vacuum Tubing 7/8" X 6' X recalled by Microtek Medical	Microtek Medical	Foreign Material	Nationwide
8 Apr 2015	CLASS II	Integral Wand W/tubing, Sterile recalled by Microtek Medical	Microtek Medical	Foreign Material	Nationwide
8 Apr 2015	CLASS II	(S) TUBE SET 1/4" X 10' X with 7/8" Adaptor, Sterile recalled	Microtek Medical	Foreign Material	Nationwide
8 Apr 2015	CLASS II	Freedomaire(r) Helmet System With Super Power Pak Battery recalled	Microtek Medical	Foreign Material	Nationwide
8 Apr 2015	CLASS II	Freedomaire(r) Helmet System With Belt recalled by Microtek Medical	Microtek Medical	Foreign Material	Nationwide
8 Apr 2015	CLASS II	Freedomaire(r) Helmet With Motor Module recalled by Microtek Medical	Microtek Medical	Foreign Material	Nationwide
8 Apr 2015	CLASS II	Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' x recalled	Microtek Medical	Foreign Material	Nationwide
8 Apr 2015	CLASS II	Freedomaire(r) Motor Module recalled by Microtek Medical	Microtek Medical	Foreign Material	Nationwide
8 Apr 2015	CLASS II	Tubing Set 7/8" X 6' With 1/4" x 24" Tubing recalled by Microtek Medical	Microtek Medical	Foreign Material	Nationwide
8 Apr 2015	CLASS II	Tubing 7/8' X 10', W/wand & Tip, 24/cs recalled by Microtek Medical	Microtek Medical	Foreign Material	Nationwide
8 Apr 2015	CLASS II	Laparoscopic Tubing Set, 3/16" ¿ X 10' x With Male Luer recalled	Microtek Medical	Foreign Material	Nationwide
8 Apr 2015	CLASS II	Laser Resistant Wand - Sterile, 7/8" X 8" x recalled by Microtek Medical	Microtek Medical	Foreign Material	Nationwide

More recalls from Microtek Medical

All 20

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Other Surgical Instruments recalls

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Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
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