Microtek Medical Inc: Medical Device Recall in 2015 - (Recall #: Z-1348-2015)

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:

LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NO LATEX 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-1348-2015

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: 6540 units

Code Information:

Lot Numbers: C10102, C10141, C10161, C10326, C10341, C11024, C11055, C11098, C11153, C11215, C11265, C11284, C11326, C11342, C12020, C12101, C12152, C12201, C12276, C12339, C13031, C13100, C13175, C13254, C13291, C14052

Distribution Pattern:

US (nationwide) Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated