Recall record at a glance
| Official record | Z-0494-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Aircraft Medical Limited |
| Report date | Dec 10, 2014 |
| Recall initiation date | Nov 4, 2014 |
| Quantity | 40,900 blades (US); 16,000 blades (Foreign) |
| Location | EDINBURGH, N/A, United Kingdom |
Official product description
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
Why the product was recalled
The blade retaining clip may be difficult to engage and thereby increase the possibility of a blade becoming disconnected during intubation, specifically when the device is being retracted from the patients mouth.
Distribution information
Worldwide Distribution - US Nationwide in the state of GA and the countries of Austria, China, Denmark, Finland, France, Hong Kong, Israel, Italy, Netherlands, Poland, Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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