Maquet Aortic Arterial Cannula Recall Due to De-airing Plug Breakage Risk
Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas because the de-airing plugs may break during removal.
What this means for you
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 and involves a risk of harm (plug breakage) in a medical device without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiopulmonary Ag is recalling 150 units of Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. The affected lots are 92180017, 92183437, and 92184278. These devices are intended for use in cardiopulmonary bypass.
The recall was initiated because the arterial cannulas may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. The FDA has classified this as a Class II recall.
The affected products were distributed worldwide, including the United States (specifically Virginia and Puerto Rico), Australia, Belgium, Brazil, Canada, Chile, Colombia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Martinique, Mauritius, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, and the United Kingdom. Healthcare facilities should stop using the affected devices and contact the manufacturer for instructions.
The recalled product
- Product
- Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass
- Manufacturer
- Maquet Cardiopulmonary Ag
- Hazard
- Affected units
- 150
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 (3)
- UDI CODE: 04037691239804
- Lot Number: 92180017
- 92183437 and 92184278
Distribution
Part of a larger recall action
This product is one of 3 recalled by Maquet Cardiopulmonary Ag under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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