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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SUBCHAPTER 7.1 - RECALLS

7.1 - RECALLS
7.1.1 - DEFINITIONS
     7.1.1.1 - Recall
     7.1.1.2 - Recall Classification
        7.1.1.2.1 - CLASS I RECALL
        7.1.1.2.2 - CLASS II RECALL
        7.1.1.2.3 - CLASS III RECALL
     7.1.1.3 - Recall Type
     7.1.1.4 - Recall Strategy
     7.1.1.5 - Depth of Recall
     7.1.1.6 - Recall Number
     7.1.1.7 - Medical Device Notification Order
     7.1.1.8 - Medical Device Notification
     7.1.1.9 - Medical Device Safety Alert


7.1 - RECALLS


7.1.1 - DEFINITIONS


7.1.1.1 - Recall

A Recall is a firm's removal or correction of a marketed product that FDA considers to be in violation of the laws it administers, and against which the Agency would initiate legal action (e.g., seizure). Recall does not include a market withdrawal or a stock recovery. See the Agency recall policy outlined in 21 CFR 7.1/7.59 - Enforcement Policy - General Provisions, Recalls (Including Product Corrections) - Guidance on Policy, Procedures and Industry Responsibilities.


7.1.1.2 - Recall Classification

Recall Classification is the numerical designation, i.e., I, II, or III, assigned by the FDA to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled.


7.1.1.2.1 - CLASS I RECALL

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.


7.1.1.2.2 - CLASS II RECALL

Class II Recall 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.


7.1.1.2.3 - CLASS III RECALL

Class III Recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.


7.1.1.3 - Recall Type

Recall type is a designation based on whether the recall is Voluntary, FDA Requested (at the request of the Commissioner or his/her designee), or ordered under section 518(e) of the FD & C Act [21 U.S.C 360h (e)].


7.1.1.4 - Recall Strategy

Recall strategy is a planned specific course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effective­ness checks for the recall.


7.1.1.5 - Depth of Recall

Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, i.e., wholesaler, retailer, user/consumer, which is known as the depth of recall.


7.1.1.6 - Recall Number

The recall number is the number assigned, by a responsible Center, for each recalled product they initiate. This number consists first of a letter designating the responsible Center (see letter Codes below), a 3 or 4 digit sequential number indicating the number of recalls initiated by that Center during the fiscal year, and a 4-digit number (the Center for Devices and Radio­logical Health (CDRH) uses 2-digit numbers) indicating the fiscal year the recall was initiated. For example: F-100-2011 identifies the 100th recall initiated by the Center for Food Safety and Applied Nutrition (CFSAN) in FY-2011. The following letters are used to identify the Centers.

LetterCenter/Office
FFoods - CFSAN
DDrugs - Center for Drug Evaluation and Research (CDER)
ZMedical Devices & Radiological Health - CDRH
VVeterinary Medicine - Center for Veterinary Medicine (CVM)
BBiologics - Center for Biologics Evaluation and Research (CBER)
NMedical Devices (Voluntary Safety Alerts and Notifications)
AAudit Numbers issued by the District performing the recall, the Centers, Office of Enforcement (Di-vision of Compliance Management and Operations [DCMO], or the Division of Domestic Field Investigations (DFI) to monitor recalls requiring audit checks.


7.1.1.7 - Medical Device Notification Order

A medical device notification order is an order issued by FDA requiring notification under section 518(a) of the FD & C Act [21 U.S.C. 360h (a)]. The directive issues when FDA determines a device in commercial distribution, and intended for human use, presents an unreasonable risk of substantial harm to the public health. The notification is necessary to eliminate the unreasonable risk of such harm, and no more practicable means is available under the provisions of the Act to eliminate such risk.


7.1.1.8 - Medical Device Notification

A medical device notification is a communication issued by the manufacturer, distributor, or other responsible person in compliance with a Notification Order. It notifies health professionals and other appropriate persons of an unreasonable risk of substantial harm to the public health presented by a device in commercial distribution.


7.1.1.9 - Medical Device Safety Alert

A medical device safety alert is a communication voluntarily issued by a manufacturer, distributor, or other responsible person (including FDA). It informs health professionals and other appropriate persons of a situation which may present an unreasonable risk to the public health by a device in commercial distribution.

NOTE: Medical Device Notifications and Safety Alerts as described in IOM 7.1.1.7, 7.1.1.8, and 7.1.1.9 are to be handled by the Districts as recalls. They will go through the stages of alert, recommendation, classification, field notification, firm notification letter, firm effectiveness checks and status reports, FDA audit checks and termination recommendations.