Class I Recall definition

Class I Recall means a recall in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Class I Recall means the classification by a Regulatory Agency that there is a reasonable probability that the use or consumption of an Insured Product(s) will cause serious adverse health consequences or death.

Examples of Class I Recall in a sentence

• Class I - A Class I Recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

• See Medical Device Recalls, Class I Recall: Boston Scientific Express Coronary Stent, at [http://www.fda.gov/cdrh/recalls/recall-071604.html], and Medical Device Recalls, Class I Recall: Boston Scientific Taxus Express Coronary Stent, at [http://www.fda.gov/ cdrh/recalls/recall-070104.html].

• If by reason of a default under the Mortgage upon the Leased Premises, the interest of Landlord in the Leased Premises is terminated, the Tenant will attorn to Landlord's Mortgagee at Landlord's mortgagee's sole option (or to any person or entity to which the Leased Premises is conveyed by such holder) and will recognize such holder, person or entity as Tenant's landlord under this Lease.

• The division coordinator will have to determine that all applicable and required data is included before submitting the Class I "Recall Termination Recommendation" to the Center recall unit for concurrence.

• The drug regulatory authority of the province, autonomous region or municipality directly under the central government shall timely submit the information about Class I Recall to the State Food and Drug Administration.

• Section 18.1 In the event any cargo shipped hereunder is recalled pursuant to a Class I Recall under regulatory standards promulgated by the U.S.D.A. (“Recall”), whether initiated by Carrier or by decision, action or order of any governmental authority due to the actions of Carrier, Carrier shall notify Shipper via direct telephone prior to the implementation of such Recall.

• The PET ring was the subject of an FDA Class I Recall in 2005, 2006, and 2007.

• The blue solid line represents the predicted probabilities and the dashed black lines represent the 95% confidence intervals.Figure 3.3: Predicted Probabilities with 95% Confidence Intervals (Model 2).

• Request for Concurrence on Class I Recall Classification,“ December 22,1982.

• On December 21, 2011, the FDA reclassified St. Jude’s Dear Doctor advisories to a Class I Recall.