United StatesWhat's being recalled
Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUARD 5/64 X 3/4 - BLUE, Model Number 09-1-012; 4) BLUE VENTED INSTRUMENT GUARD 5/64 X 3/4, Model Number 09-1-012; 5) VENTED INSTRUMENT GUARD 7/64 X 3/4 - GREEN, Model Number 09-1-013; 6) GREEN VENTED INSTRUMENT GUARD 7/64 X 3/4, Model Number 09-1-013; 7) VENTED INSTRUMENT GUARD 1/8 X 1 - RED, Model Number 09-1-014; 8) RED VENTED INSTRUMENT GUARD 1/8 X 1, Model Number 09-1-014; 9) VENTED INSTRUMENT GUARD 3/16 X 1 - YELLOW, Model Number 09-1-015; 10) YELLOW VENTED INSTRUMENT GUARD 3/16 X 1, Model…
Recalling firm: Healthmark Industries Co., Inc., Fraser, MI, United States.
How to identify it
Model Number 09-1-011, UDI DI 00840113213610, Lot Number 46313; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 48704; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 52563; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 54316; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 56859; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 62805; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 66222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 68451; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 70818; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 76638; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 77955; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 85979; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 88504; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 091011; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 92954; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 93535; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 95456; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 96593; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 99366; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 103829; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 107222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 112086; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 116183; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 125652; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 130885; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 141843; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 145497; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 149058; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 154671; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 161613; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 166797…
The hazard
Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA, CANADA, PORTUGAL, FRANCE, POLAND, PUERTO RICO, SAUDI ARABIA, HONG KONG, BAHRAIN, QATAR, OMAN, ISRAEL, MEXICO, UNITED ARAB EMIRATES, SINGAPORE, BERMUDA, SOUTH KOREA, THAILAND, and UNITED KINGDOM.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)