Recall Z-0344-2016— Stryker Medical Division of Stryker Corporation

Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2015-10-13, terminated 2016-09-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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.

Recalling firm

Stryker Medical Division of Stryker Corporation

Classification

Class II

Status

Terminated

Initiated

2015-10-13

Terminated

2016-09-06

Firm location

Portage, MI, United States

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