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U.S. Department of Health and Human Services

Class 2 Device Recall 3.0 Liter Disposable Set (4 sets/case)

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 Class 2 Device Recall 3.0 Liter Disposable Set (4 sets/case)see related information
Date Initiated by FirmMarch 31, 2025
Date PostedApril 25, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1678-2025
Recall Event ID 96625
510(K)NumberK242735 
Product Classification Warmer, thermal, infusion fluid - Product Code LGZ
Product3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the same case for shipment. The female quick connector that may be cracked is located on the Heat Exchanger/Patient Line set.
Code Information Model Number: 903-00032. UDI-DI: 00896128002534. Lot Numbers: 20240911, 20241004, 20241011, 20241105
FEI Number 1219702
Recalling Firm/
Manufacturer		 Belmont Instrument LLC
780 Boston Rd
Billerica MA 01821-5925
For Additional Information ContactLida Reed
978-696-9245
Manufacturer Reason
for Recall		Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
FDA Determined
Cause 2		Process design
ActionBelmont Medical notified consignees on about 03/31/2025 via "URGENT MEDICAL DEVICE CORECTION" FedEx or emailed letter. Consignees were instructed to locate affected product and to return the customer Response Form indicating if any affected units were on hand. Consignees were also instructed to follow instructions provided in the letter to inspect affected lots and if any units are identified as having cracks or leaks during priming, they should be discarded. Lot number of the set should be noted and reported to Belmont Medical Technologies. Belmont has indicated that they will replace any product found defective or at the request of the user any affected product that has not been used.
Quantity in Commerce603 cases (2,412 sets)
DistributionNationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI. International distribution to Czechia, Italy, Norway.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LGZ
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