Maquet Getinge Rapid Response Universal Packs Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling Rapid Response Universal Packs because a design flaw may prevent proper sterilization of the stopcock ports.
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 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: The recall is classified as FDA Class II and involves a failure to assure sterility in a medical device used for extracorporeal circulation, which carries a significant risk of serious injury or infection.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge BO-TOP 13901 Rapid Response Universal Packs (Material 701054874R01). The recall involves specific batch numbers: 3000077890 and 3000079608. The products were distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which poses a risk of infection if the devices are used for extracorporeal circulation.
Healthcare facilities and users should stop using the affected products immediately and contact Maquet Cardiovascular for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 701054874R01
- Manufacturer
- Maquet Cardiovascular, LLC
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 (1)
- Batch Numbers: 3000077890 3000079608
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 183 recalled by Maquet Cardiovascular, LLC 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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