Health Canada — Medical Devices · Canada · 2014-11-07 · Type III
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Archived by the issuing authority — kept for reference
Reported risk: 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.
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.