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.
FDA Recall Z-0344-2016 · Posted None
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Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeFOX
Date Initiated2015-10-13
Date Terminated2016-09-06
Product Quantity19,876
Reason for Recall
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
Firm Action
On 10/13/2015, URGENT MEDICAL DEVICE NOTIFICATION letters were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m-5 p.m. (ET).
Root Cause
Process control
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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