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" II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. "
Oversight of VA Pacemaker Policy: Hearing Before the Committee on Veterans ... - Page 3
by United States. Congress. Senate. Committee on Veterans' Affairs - 1980 - 190 pages
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The Code of Federal Regulations of the United States of America

Administrative law - 1995 - 440 pages
...indicate the relative degree of health hazard presented by the product being recalled. (1) Class I is a situation in which there is a reasonable probability...cause serious adverse health consequences or death. (2) Class II is a situation in which use of, or exposure to, a violative product may cause temporary...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2000 - 544 pages
...indicate the relative degree of health hazard presented by the product being recalled. (1) Class I is a situation in which there is a reasonable probability...cause serious adverse health consequences or death. (2) Class П is a situation in which use of, or exposure to, a violative product may cause temporary...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1987 - 454 pages
...indicate the relative degree of health hazard presented by the product being recalled. (1) Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violatlve product will cause serious adverse health consequences or death. (2) Class II is a situation...
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FDA Consumer, Volume 18

Consumer protection - 1984 - 412 pages
...subjected to a Class I recall. (A recall is designated Class I when there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse consequences or death.) Award Services Inc. had recalled the chew toys, and approximately $30,000 worth...
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Food Safety and Quality: Hearings Before the Subcommittee on ..., Volumes 1-2

United States. Congress. Senate. Committee on Agriculture, Nutrition, and Forestry. Subcommittee on Agricultural Research and General Legislation - Antibiotics in animal nutrition - 1977 - 726 pages
...indicates the relative degree of health hazard presented by the product being recalled. (1) Class I is a situation in which there is a reasonable probability...cause serious adverse health consequences or death. (2) Class II is a situation in which use of, or exposure to, a violative product may cause temporary...
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Infant Formula: Our Children Need Better Protection: Report Together with ...

United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Oversight and Investigations - Food law and legislation - 1980 - 54 pages
...and disregarding FDA regulations which distinguish between Class I and Class II recalls: Class I is a situation in which there is a reasonable probability...serious adverse health consequences or death. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically...
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Infant Formula: Hearing Before the Subcommittee on Oversight and ...

United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Oversight and Investigations - Infant formulas - 1980 - 128 pages
...Evaluation Board indicated this problem was life threatening. The regulations state that the class 1 is a situation in which there is a reasonable probability that the use of, or exposure to, this product will cause serious adverse health consequences or death. Reasonable probability of death...
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Infant Formula: Hearing Before the Subcommittee on Oversight and ...

United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Oversight and Investigations - Infant formulas - 1980 - 276 pages
...and class 2, are they not? Dr. GOYAN. They appear to be. Mr. GORE. The last one is a situation where there is a reasonable probability that the use of or exposure to a volatile product will alth consequences or death. Is that correct? Dr. GOYAN. Correct. Mr. GORE. The...
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Drug Misuse and Adverse Drug Reactions Among the Elderly: A Briefing

Medication abuse - 1983 - 52 pages
...withdrawals and stock recoveries. These are defined as follows: Class I recalls. — A class I recall is a situation in which there is a reasonable probability that the use of, or exposure to a violated product, will cause serious adverse health consequences or death. Class II recalls. — A...
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The Cosmetic Industry: Scientific and Regulatory Foundations

Estrin - Medical - 1984 - 734 pages
...Classification Recalls can be classified into three categories. Class I recall: A Class I recall refers to a situation in which there is a reasonable probability...cause serious, adverse health consequences or death. Examples of Class I recall situations include: 1. Label mix-up of potent drug 2. C. botulinum toxin...
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