Stolen McGRATH MAC Video Laryngoscopes Recalled for Failed Quality Tests
Covidien recalls 5,709 stolen McGRATH MAC video laryngoscopes that failed quality tests. These defective devices risk failed intubation and may compromise airway management.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification establishes a minimum severity score of 4 per recall guidelines. Although no illnesses or injuries have been documented in the source, the potential for failed intubation during airway management represents a significant risk of serious harm in clinical use.
Plain-English summary
Covidien is recalling 5,709 McGRATH MAC video laryngoscopes (Model 301-000-000) used for airway management and intubation procedures. The recalled devices failed mandatory quality control tests and were originally designated for destruction.
These defective devices were stolen and subsequently distributed for sale. The stolen units lack proper packaging and labeling, and some units lack serial numbers.
Use of these defective laryngoscopes may result in failed laryngoscopy and/or intubation during clinical procedures. Persons using or relying on these devices should cease use immediately.
Healthcare facilities and consumers who have these devices should contact Covidien for device replacement or disposal instructions. The FDA enforcement notice provides the complete list of affected serial numbers.
The recalled product
- Product
- Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
- Manufacturer
- Covidien
- Affected units
- 5,709
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 (20)
- 20884521823393. Known Affected Serial Numbers: 000063
- 000076
- 000085
- 000092
- 000093
- 000112
- 000120
- 000121
- 000146
- 000153
- 000154
- 000155
- 000166
- 000179
- 000190
- 000197
- 000202
- 000224
- 000233
- 000238
Distribution
Distribution scope not specified by the agency.
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