Recall Z-1673-2021— Welch Allyn Inc

Name: FDA recall Z-1673-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-22

Class II · Terminated

Class II FDA medical device recall by Welch Allyn Inc, initiated 2021-04-22, terminated 2024-05-31. It names one FDA 510(k) clearance: K101680. Product: ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).. Reason: Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock.

Recalling firm: Welch Allyn Inc
Classification: Class II
Status: Terminated
Initiated: 2021-04-22
Terminated: 2024-05-31
Firm location: Skaneateles Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K101680 — WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIESWelch Allyn, Inc.·cleared 2010-07-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).

Reason for recall

Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock

Data sourced from openFDA. This site is unofficial and independent of the FDA.