Stryker Medical Division of Stryker Corporation recalls Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are sta…

Recall date

October 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0344-2016

FDA classification

Class II

Brand / firm

Stryker Medical Division of Stryker Corporation

Sold / distributed

Worldwide Distribution-US (nationwide) including DC and Guam, and the countries of New Zealand Canada Chile Hong Kong Colombia Argentina Brazil France Germany Italy Netherlands Spain Switzerland United Kingdom India Japan South Korea Mexico South Africa Poland Singapore.

Why it was recalled

It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated which identified that the I.V. Latch Housing was nonconforming. potential hazards: " Suspended I.V. pole retracts unexpectedly " Suspended I.V. pole retracts unexpectedly with pump/bags attached

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following parent devices: Model 2030 (EPIC II), model 3005 S3 beds and stretcher. models 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 1115XE, 1125E, 1125X and 1125XE.