Reported Jun 18, 2025 · Ongoing
Allon 2001. Part Number: 200-00263
Belmont Instrument LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Belmont Instrument LLC · 780 Boston Rd · Billerica, MA · 01821-5925
Is this the product you have?
- Allon 2001
- Part Number200-00263
- Lot codes and dates
- Part Number200-00263
- UDI-DI007290107581103
- Serial Numbers
230 of 230 codes
9911114300000299111143000014991116273000349993901600001999390160000299939016000049993901600006999390160000799939016000099995356300005999535630000699953563000079995356300008999667380000299111143000001991111430000039911114300000499111143000007991111430000089911114300000999111143000011991111430000129911114300001399111143000015991111430000189911114300001999111288700016991112887000219911128870003599111288700036991116273000119911162730001799111627300022991116273000299911162730004099111627300041991116273000459911162730004699111627300054991116273000579911162730006499111627300067991131683000049911316830000599113168300008991131683000109911316830001299128623400008991296147000029912961470000599131046400001991310464000039913104640000499131046400005991310464000069913104640000999131046400011991310465000079913273240000999132732400018
- Amount recalled
- 229 units
Where it was sold
Why it was recalled
An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.
This product could cause temporary or reversible health problems — stop using it.
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