Baxter Peritoneal Dialysis (PD) Transfer Sets, Titanium Adapters; Disconnect Caps and Connection Shield Products (2014-12-18)

Starting date:

December 18, 2014

Posting date:

January 29, 2015

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-43427

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  Reason
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  Affected products

Recalled Products

A) Connection Shield Sys II with Iodine

B) Connection Shield Sys IIK with Iodine

C) Opticap Disconnect Cap with Iodine

D) Minicap Disconnect Cap with Iodine

E) Minicap Ext Life PD Trans, Twist, XLong

Reason

Baxter is sending an important safety update to the instructions for use for Baxter Peritoneal Dialysis (PD) transfer sets, titanium adapters; disconnect caps and connection shield product codes. Specifically, Baxter is adding contraindication statements to address iodine allergy for Baxter's PD products which contain iodine (i.e., povidone iodine) or for which iodine use is recommended. There is no product hold or physical removal of devices from the field associated with this action.

Affected products