The Recall Desk
SevereFDA (Devices)·Z-1777-2017·Announced 2017-04-19

Welch Allyn ProBP 2400 Digital Blood Pressure Device Recall

Welch Allyn is recalling 981 ProBP 2400 digital blood pressure devices due to a defective electrical component that may cause over-voltage battery charging and melting of plastic parts.

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 source text describes a defect that can cause melting of plastic components due to high temperatures, which constitutes a significant injury risk (burns) and property damage, aligning with the 'Severe' criteria for significant injury/property-damage reports or structural defects.

Plain-English summary

Welch Allyn Inc. is recalling 981 units of the ProBP 2400 Digital Blood Pressure Device (REF 901096) distributed worldwide, including nationwide in the United States. The recall affects two specific lots: Lot Number 0715 (Serial Number range 07150001 - 07150620) and Lot Number 1215 (Serial Number range 12150001 - 12150500). Note that the prefix (21) on GUDI compliant labels is not part of the serial number.

The recall is due to a defective electrical component in the battery charging circuit. This defect may cause an over-voltage battery charging condition when the device is connected to an external power supply or battery charger. The over-voltage condition can result in high temperatures in the NiMH battery, which in some cases can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components. The defect resides with the device itself, not the battery.

Consumers should stop using the affected devices and contact Welch Allyn Inc. for instructions on how to proceed. The agency has classified this as a Class II recall.

The recalled product

Product
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. --- Micro
Manufacturer
Welch Allyn Inc
Category
Medical Device — Blood Pressure Monitor
Hazard
Affected units
981

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Number 0715: Serial Number range (21)07150001 -  (21)07150620
  • Lot Number 1215: Serial Number range (21)12150001 -  (21)12150500

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Welch Allyn Inc

See all →