Maquet Recalls Expired Hemofiltration Standard Packs for Cardiopulmonary Bypass
Maquet is recalling 55 Hemofiltration Standard Packs distributed after their September 2015 expiration date. The units were used in extracorporeal circulation during cardiopulmonary bypass procedures.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is limited to the use of expired medical devices, which fits the criteria for a moderate severity score.
Plain-English summary
Maquet is recalling 55 units of the Hemofiltration Standard Pack, including the BC 60 Plus-T 8036 (Part Number: 701066990). These medical devices are used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
The recall was initiated because the 55 kits were distributed after their expiration date of September 2015. The affected units are identified by Lot/batch number 3000001571 and UDI code 607567206489.
The affected products were distributed to the states of New Mexico, California, and Illinois. Healthcare facilities and consumers should stop using these specific units and contact Maquet for further instructions.
The recalled product
- Product
- Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.
- Manufacturer
- Maquet
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 55
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)
- Lot/batch number: 3000001571 UDI code: 607567206489
Distribution
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