Aircraft Medical Recalls McGrath MAC2 Video Laryngoscope Blades
Aircraft Medical Limited is recalling McGrath MAC2 Video Laryngoscope Blades because the retaining clip may be difficult to engage, increasing the risk of the blade disconnecting during intubation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves a risk of harm (blade disconnection during intubation) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Aircraft Medical Limited is recalling McGrath MAC2 Video Laryngoscope Blades, which are single-use, sterile video laryngoscope blades supplied in boxes of 50. The recall involves 40,900 blades in the United States and 16,000 blades distributed internationally.
The recall was initiated because the blade retaining clip may be difficult to engage. This defect increases the possibility of the blade becoming disconnected during intubation, specifically when the device is being retracted from the patient's mouth.
The affected product is distributed worldwide, including in the United States (specifically the state of Georgia) and in Austria, China, Denmark, Finland, France, Hong Kong, Israel, Italy, Netherlands, Poland, Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey. Healthcare providers should stop using the affected blades and contact Aircraft Medical Limited for instructions on return or replacement.
The recalled product
- Product
- McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes
- Manufacturer
- Aircraft Medical Limited
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 (12)
- Product Code: 350-017-000. Lot Numbers and Expiration Dates: Lot 13121202
- Expires 2016/12/11
- Lot 13122301
- Expires 2016/12/25
- Lot 13042401
- Expires 2017/5/5
- Lot 14030501
- Expires 2017/3/16
- Lot 14031814
- Expires 2017/3/26
- Lot 14061616
- Expires 2017/6/25.
Distribution
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