ONE-LINK Non-DEHP Y-Type, ONE-LINK Non-DEHP and Bonded ONE-LINK Non-DEHP Microbore Sets (2014-11-24)

Starting date:

November 24, 2014

Posting date:

December 5, 2014

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-42767

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  Reason
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  Affected products

Recalled Products

A) ONE-LINK Non-DEHP Y-Type Microbore Sets

B) ONE-LINK Non-DEHP Microbore Sets

C) Bonded ONE-LINK Non-DEHP Microbore Sets

Reason

Baxter corporation is notifying customers of an incompatible product that should not be used with specific one-link devices. Customers have reported no-flow and restricted flow situations when attempting to connect the microclave device to the male luer lock adapter of the one-link catheter extension set in product code 7N8371. Baxter's investigation has determined that the microclave dimensions are not compatible with the ISO-compliant male luer adapter dimensions of the affected one-link product codes. Under-infusion or interruption of therapy could result.

Affected products