Maquet Getinge NICU ECC Pack Recall Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling NICU ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the failure of a sterilization assurance level for a medical device used in extracorporeal circulation represents a significant risk of serious harm (infection), fitting the 'Severe' criteria for Class II devices with potential for serious injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge BEQ-TOP 39202 NICU ECC Packs (Material: 701067313R01) due to a potential sterility assurance issue. The recall is classified as Class II by the FDA.
The recall is issued because the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the cap during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
The affected products were distributed nationwide. Specific batch numbers involved in the recall are 3000043846, 3000047255, 3000052044, 3000061508, 3000074098, 3000078928, and 3000079607. Healthcare facilities should check their inventory for these specific batch numbers and follow the instructions provided by the recalling firm.
The recalled product
- Product
- Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01
- Manufacturer
- Maquet Cardiovascular, LLC
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.
See all 183 products in this recall →Related recalls
Same manufacturer · Maquet Cardiovascular, LLC
See all →- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- HighVessel harvesting systems recalled after out-of-box failures in harvesting tool jaws
FDA (Devices) · 2025-10-01
- HighHeartstring III seal systems recalled over failures to load, deploy and seal
FDA (Devices) · 2025-09-24
- HighHeartstring III 4.3 mm seal systems recalled over loading and deployment failures
FDA (Devices) · 2025-09-24
- HighHeartstring III 3.8 mm seal systems recalled over three identified failure modes
FDA (Devices) · 2025-09-24
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22