FDA (Devices) recall action 70721

Microtek Medical Inc recalled 13 products on 2015-04-08

The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.

Products: 13
Announced: 2015-04-08
Critical: 0
Units: 145,758

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–13 of 13

HighFDA (Devices)··2015-04-08
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.
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…
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ModerateFDA (Devices)··2015-04-08
Microtek Medical Recalls Sterile Laser Resistant Wands Due to Latex Packaging
Microtek Medical Inc is recalling sterile laser resistant wands because the packaging contains latex but lacks the required warning label.
Product
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.…
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ModerateFDA (Devices)··2015-04-08
Microtek Medical Recalls Freedomaire Surgical Helmet Systems Due to Latex Packaging
Microtek Medical is recalling 10 Freedomaire Surgical Helmet Systems because the packaging contains latex but lacks the required warning label.
Product
FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical…
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ModerateFDA (Devices)··2015-04-08
Microtek Smoke Evacuation Tubing Set Recalled for Latex Packaging Labeling Error
Microtek Medical Inc is recalling 303 Smoke Evacuation Tubing Sets because the packaging contains latex but lacks the required warning label.
Product
Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool…
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HighFDA (Devices)··2015-04-08
Microtek Medical Recalls Surgical Helmet Motor Modules for Latex Packaging
Microtek Medical Inc is recalling 38 units of FREEDOMAIRE Motor Modules because the packaging contains latex but lacks the required warning label.
Product
FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body…
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ModerateFDA (Devices)··2015-04-08
Microtek Medical Smoke Evacuator Tube Sets Recalled for Latex Packaging
Microtek Medical Inc is recalling sterile smoke evacuator tube sets because the packaging contains latex without the required warning label.
Product
(S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, 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…
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ModerateFDA (Devices)··2015-04-08
Microtek Medical Smoke Evacuator Tubing Recalled for Unlabeled Latex Packaging
Microtek Medical is recalling smoke evacuator tubing because the packaging contains latex but lacks the required warning label.
Product
TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, 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…
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HighFDA (Devices)··2015-04-08
Microtek Medical Smoke Evacuator Tubing Set Recalled for Latex Packaging
Microtek Medical is recalling smoke evacuator tubing sets because the packaging contains latex but lacks the required warning label.
Product
TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, 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…
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ModerateFDA (Devices)··2015-04-08
Microtek Medical recalls sterile smoke evacuator wands due to latex packaging
Microtek Medical is recalling sterile smoke evacuator wands because the packaging contains latex but lacks the required warning label.
Product
INTEGRAL WAND W/TUBING, STERILE, REF 24185, 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…
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ModerateFDA (Devices)··2015-04-08
Microtek Medical Recalls Freedomaire Surgical Helmets Due to Latex Packaging
Microtek Medical Inc is recalling 11 units of Freedomaire Surgical Helmet Systems because the packaging contains latex but lacks the required warning label.
Product
FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against…
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ModerateFDA (Devices)··2015-04-08
Microtek Medical Recalls Sterile Vacuum Tubing Due to Unlabeled Latex Packaging
Microtek Medical Inc is recalling sterile vacuum tubing because the packaging contains latex but lacks the required warning label.
Product
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.…
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0 states
ModerateFDA (Devices)··2015-04-08
Microtek Medical Recalls Freedomaire Surgical Helmets Due to Latex Packaging
Microtek Medical Inc is recalling 153 Freedomaire Surgical Helmets because the packaging contains latex but lacks the required warning label.
Product
FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against…
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ModerateFDA (Devices)··2015-04-08
Microtek Medical Recalls Vacuum Tubing Due to Unlabeled Latex Packaging
Microtek Medical Inc is recalling non-sterile vacuum tubing because the packaging contains latex but lacks the required warning label.
Product
VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE 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…
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