CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report
Laparoscopic Tubing Set, 3/16" ¿ X 10' x With Male Luer recalled
Microtek Medical is recalling Laparoscopic Tubing Set, 3/16" ¿ X 10' x With Male Luer Lock - 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
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-1341-2015
- 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
LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/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.
Questions about this recall
Is Laparoscopic Tubing Set, 3/16" ¿ X 10' x With Male Luer Lock - Sterile recalled?
Yes. Microtek Medical recalled Laparoscopic Tubing Set, 3/16" ¿ X 10' x With Male Luer Lock - Sterile on 10 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1341-2015.
Why was it recalled?
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.
Which lots are affected?
Lot Numbers: C10104, C10272, C11080, C14052
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |