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U.S. Department of Health and Human Services

Class 2 Device Recall Rotating IV Pole

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 Class 2 Device Recall Rotating IV Polesee related information
Date Initiated by FirmDecember 01, 2017
Create DateMarch 26, 2018
Recall Status1 Terminated 3 on September 17, 2019
Recall NumberZ-1181-2018
Recall Event ID 79452
Product Classification Stand, infusion - Product Code FOX
ProductRotating 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.
Code Information Model Number(s): 6600-0851-800 Affected lot codes are within LAU13921134 - LAU14720444
FEI Number 1121732
Recalling Firm/
Manufacturer		 Ohmeda Medical
8880 Gorman Rd
Laurel MD 20723-5800
For Additional Information Contact
410-888-5376
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionOn 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.
Quantity in Commerce1,179 (1,004 US; 175 OUS)
DistributionUSA (nationwide)
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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