Kool-Kit Neonate (2014-11-03)

Starting date:

November 3, 2014

Posting date:

November 7, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-42081

• Reason
• Affected products

Recalled Products

Kool-Kit Neonate

Reason

Cincinnati Sub-Zero Products Inc. (CSZ) has initiated a correction on this medical device due to the omission of the probe IFU from the Kool-kit neonate. The Kool-kit neonate has been designed such that 1 of the individually packaged cat #491B probes is required for each tray. Since the probes are received from their manufacturer in cartons containing 20 probes and 1 IFU, 1 carton of probes will make 20 Kool-kit neonate trays. The probe IFU has not been used during assembly of the Kool-kit neonate trays since the product was first released for sale on 3/27/2009. However, since the probe pouches are labeled with a 3 year shelf life, this correction only applies to Kool-kit neonates manufactured within the last 3 years. The probe IFU includes additional information that is not included within the labeling provided to the customer by CSZ.

Affected products