missionemp10039_415_AD200082 Product Recalls - Mission Health

Recalls, Product -- #200.082 Page: 2 Of: 4=====================================================================FDA Classification of Recalls:Class I Recalls ……… Dangerous or defective products that could cause serious health problems ordeath.Class II Recalls …….. Products that may cause a temporary health problem or medically reversibleadverse health consequences.Class III Recalls ……. Products that are unlikely to cause adverse health consequences but violateFDA regulations. An example is aspirin bottles containing 90 tablets insteadof 100, as stated on the product label.Market Withdrawal … Occurs when a product has a minor violation that would not be subject toFDA legal Action. The firm/supplier removes the product from the marketor corrects the violation.Medical Device Is issued in situations where a medical device may present an unreasonableSafety Alert ……….. risk of substantial harm. In some cases, these situations also are consideredrecalls.Source: U.S. Food and Drug AdministrationPROCEDURE:1. Initial recall notifications and medical device/equipment hazard reporting may be maileddirectly to Administration, Risk Management, specific departments and others. Upon directnotification to the department, recalls and advisories are to be forwarded to the MMRC. Afterevaluation by the MMRC, the recall may be forwarded to Biomed, the Pharmacy or, if amedical/surgical product, the MMRC will investigate, track, notify and distribute toappropriate units.2. Upon receipt of the recall by the MMRC/designee, Director of Pharmacy or Biomed/designee,will determine which hospital departments may have the involved product, and will notifythose departments. The Corporate Safety Department will keep appropriate records of therecall/advisory and the recommended action.3. The Recall Action Log (see Attachment A) will be sent to the contact person in thedepartment(s). When staff are notified of the recall/advisory, it is important that they respondquickly by thoroughly inventorying their department. The department(s) which may have theproduct will be responsible for implementing the following, as stated on the Recall Action Log.• Removal of product from service and return as stated on the Recall Action Log.• Modification of product; change in use instructions; stickers for packages etc.• Education of clinical staff of department and responsible area.• Completion of Recall Action Log and reporting back to Materials Management.• Note: If staff have no product to report from their department, this must be reportedas well to the Materials Management Recall Coordinator on the Recall Action Log.