Recall Z-1777-2017
Welch Allyn Inc · initiated February 27, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland
Codes / lots: Lot Number 0715: Serial Number range (21)07150001 - (21)07150620; Lot Number 1215: Serial 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.
Reason for recall
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.
FDA-determined cause: Other
Action taken
Welch Allyn sent an Urgent Medical Device Recall letter and Response Forms dated February 21, 2017. They were mailed to the first round of customers beginning on Monday February 27, 2017, via US Postal Service Priority Mail. Welch Allyn will follow up with second round of mailings to the additionally identified end users the week of March 20, 2017. All end users will be instructed to confirm that their unit is affected; and if affected, a replacement unit will be provided so that the affected unit can be returned and scrapped. --- Of the 1120 units, a total of 981 units were distributed from Welch Allyn warehouses and 139 units remained under Welch Allyn control and were not distributed. These units have since been destroyed. For further questions, please call (844) 360-8220.
Details
- Recall number
- Z-1777-2017
- Initiated
- February 27, 2017
- Terminated
- June 14, 2019
- Product code
- DXN – System, Measurement, Blood-Pressure, Non-Invasive
- Quantity
- 981 units
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution
- Recalling firm
- Welch Allyn Inc, Skaneateles Falls, NY