Vial2Bag I.V. Fluid Transfer Set (2019-01-23)

Starting date:

January 23, 2019

Posting date:

February 4, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68980

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  Reason
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  Affected products

Affected Products

Vial2Bag I.V. Fluid Transfer Set

Reason

West Pharma Services is recalling these products due to the possibility that the device may not adequately transfer the drug contents to the I.V. bag. If inadequate transfer occurs there is the potential that the device may deliver variable or unpredictable dosing. We are aware of sixteen (16) products with complaints of a similar nature since March 8, 2017, reported with the use of oxytocin in conjunction with the Vial2Bag DC 13mm in pregnant women, in connection with labour and delivery.

Affected products