JBMH Vaginal Birthing CDS & Voies Centrales (2019-12-31)

Starting date:

December 31, 2019

Posting date:

January 24, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72175

Last updated: 2020-01-24

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  Reason
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  Affected products

Affected Products

1. JBMH Vaginal Birthing CDS
2. Voies Centrales

Reason

Medline is recalling custom procedure packs containing Baxter Healthcare Corporation Clearlink System Continu¿Flo Administration Sets with ONE¿LINK Needle¿free Connectors. Baxter is issuing an Urgent Device Correction to notify customers that additional force may be required to securely connect the device. There has been one report of a serious injury associated with unintended disconnection related to this issue. To prevent connection issues, users must follow the Instructions for Use (IFU) on the product labeling.

Affected products