Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyp
FDA device recall Z-1675-2025 · posted 2025-04-25 · Open, Classified
Recall details
- Recalling firm
- Belmont Instrument LLC
- Reason for recall
- Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
- Action taken
- Belmont 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.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- LGZ
- Quantity affected
- 208 sets
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary,
- Date initiated
- 2025-03-31
- Date posted
- 2025-04-25
- Location
- Billerica, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| The Belmont Hyperthermia Pump (K152208) | Belmont Instrument Corporation | 2015-09-02 |