Microtek Medical Inc: Medical Device Recall in 2015 - (Recall #: Z-1345-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 10, 2015

Date Posted: April 8, 2015

Recall Number: Z-1345-2015

Event ID: 70721

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.

Status: Terminated

Product Quantity: 56904 units

Code Information:

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

Distribution Pattern:

US (nationwide) Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated