Recall Z-1341-2015— Microtek Medical Inc
Class II · Terminated
Class II FDA medical device recall by Microtek Medical Inc, initiated 2015-03-10, terminated 2017-01-21. It names 2 FDA 510(k) clearances: K001082, K910515. Product: 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.. Reason: 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..
- Recalling firm
- Microtek Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-10
- Terminated
- 2017-01-21
- Firm location
- Columbus, MS, United States
510(k) clearances named in this recall
2 on FDA's record- K001082 — STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
- K910515 — FREEDOM MARK III SURGICAL HELMET SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.