FDA Recall Terminated

Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.

Recall: Z-1181-2018 · Initiated December 1, 2017

Recall

Recall Number
Z-1181-2018
Event Number
79452
Firm
Ohmeda Medical
FEI Number
1121732
Product Code
FOX
Status
Terminated
Root Cause
Device Design
Initiated
December 1, 2017
Terminated
September 17, 2019
Address
8880 Gorman Rd, Laurel, MD, 20723-5800

Description

Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.

Reason

There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.

Action

On December 1, 2017 an URGENT MEDICAL DEVICE CORRECTION letter was issued to customers notifying of the recall. The letter requested customers to discontinue use of the affected Rotating IV poles and remove from Service. Place affected Rotating IV poles in a quarantine marked area. A GE Service Representative will contact you to arrange for the removal & replacement of a new IV pole. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. For further questions, please call (410) 888-5376.

Distribution

USA (nationwide)

Quantity

1,179 (1,004 US; 175 OUS)