Reported Apr 19, 2017 · Terminated
Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch…
Welch Allyn Inc.
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: Welch Allyn Inc · 4341 State Street Rd · Skaneateles Falls, NY · 13153-5300
Is this the product you have?
- Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland
- Lot codes and dates
- Lot Number 0715Serial Number range (21)07150001 - (21)07150620
- Lot Number 1215Serial Number range (21)12150001 - (21)12150500; ---
- Note(21) is NOT part of the serial number. It is the Global Unique Device Identification (GUDI) Application Identifier that precedes the serial number on any GUDI compliant label
- Amount recalled
- 981 units
Where it was sold
- Nationwide
Why it was recalled
A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. This potential defect resides with the device, not the battery. The over-voltage condition can result in high NiMH battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components.
This product could cause temporary or reversible health problems — stop using it.
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