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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod® 		see related information
Date Posted October 11, 2012
Recall Number Z-0055-2013
Product 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod®, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
Code Information Part Number (Item #) AG8049-NS, Lot # 2528655.
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente, California 92673-6212
Reason for
Recall		 ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.
Action ICU Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated September 28, 2012 to its customer. The letter identified the product, problem, and actions to be taken by the customer. The customer has been instructed to inspect their inventory for the specific lot numbers, examine for the presence of a metal cannula, and certify destruction of any affected devices. The customer letter included a Verification Form to be completed and returned. Contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com" for questions regarding this notice.
Quantity in Commerce 60
Distribution Nationwide distribution: Virginia only.
 
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