CanadaHarmonyair A-Series Surgical Lighting System (models/catalogue numbers 00013A11LT, 00013A11L, 13A11L09F, 11008835, 00013A11F, 00000011L, 00013H11L, 00011L09F, 13A11L09L, 00011L09L, 13V11L09L; lot or serial numbers with more than 10 numbers: contact the manufacturer) is affected. Steris identified that paint from the lighting system’s light head may peel or chip over time with routine cleaning, which could contaminate the sterile field, delay a procedure and/or present a risk of patient infection. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Steris Corporation, 2720 Gunter Park East, Montgomery, Alabama, United States, 36109.
How to identify it
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00013A11LT
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00013A11L
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 13A11L09F
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 11008835
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00013A11F
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00000011L
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00013H11L
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00011L09F
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 13A11L09L
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00011L09L
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 13V11L09L
The hazard
Steris identified through customer complaints that paint from the lighting system's light head may begin to peel or chip over time as a result of routine cleaning procedures. While Steris has not received any reports of paint falling from a lighting system during use, if paint particles were to enter the sterile field or fall onto a patient, this could disrupt the procedure resulting in a procedure delay and/or may present a risk of patient infection.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States