Microtek Medical Recalls Laparoscopic Tubing Sets Due to Unlabeled Latex Packaging
Microtek Medical Inc. is recalling 270 units of sterile laparoscopic tubing sets because the packaging contains latex but lacks the required warning label.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves allergen mislabeling (latex) on a medical device, which fits the rubric criterion for 'Allergen mislabeling on common allergens' or 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Microtek Medical Inc. is recalling 270 units of sterile Laparoscopic Tubing Sets, Reference 24311. The affected lots are C10104, C10272, C11080, and C14052. These devices were distributed nationwide in the United States.
The recall is being conducted because the cohesive band used to package the devices contains latex, but the product is not labeled as required by 21 CFR 801.437. Specifically, the packaging does not include the required caution statement: "The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
The intended use of these smoke evacuator accessories is to evacuate smoke created by electrosurgery, laser surgery, or power tool surgical procedures in operating rooms, trauma, endoscopy, and laparoscopy sites. Users should check their inventory for the specific lot numbers listed above and contact the manufacturer for further instructions.
The recalled product
- 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 procedu
- Manufacturer
- Microtek Medical Inc
- Affected units
- 270
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: C10104
- C10272
- C11080
- C14052
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Microtek Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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