Recall Z-1181-2018— Ohmeda Medical
Class II · Terminated
Class II FDA medical device recall by Ohmeda Medical, initiated 2017-12-01, terminated 2019-09-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Ohmeda Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-01
- Terminated
- 2019-09-17
- Firm location
- Laurel, MD, United States
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.