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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Handi-Fil Disposable Syringe Fill Tube 		see related information
Date Posted January 19, 2012
Recall Number Z-0815-2012
Product Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnati, OH Made in Mexico. The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve the projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an injection syringe.
Code Information Catalog #302050, Lot # 9288021, Exp Date 10-2012; Lot # 0011122, Exp Date 01-2013; Lot # 0095256, Exp Date 04-2013; Lot # 0127196, Exp Date 05-2013; Lot # 0253137, Exp Date 09-2013 & Lot # 0302172, Exp Date 11-2013.
Recalling Firm/
Manufacturer		 Mallinckrodt Inc
2111 E Galbraith Rd
Cincinnati, Ohio 45237-1624
Consumer Instructions Contact the recalling firm for information
Reason for
Recall		 The firm received complaints from their customers stating that they found open seals on two of their sterilized products.
Action Mallinckrodt Inc. sent an "URGENT DEVICE RECALL" letter dated December 20, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product and to complete and return an attached Business Response form via fax to (314) 654-8206 or e-mail to imaging.recalls@covidien.com. Contact the Product Monitoring Department at 800-778-7898 for questions regarding this notice.
Quantity in Commerce 63,900 units
Distribution Worldwide Distribution--USA (nationwide) including the states of AZ, CA, GA, IA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, WA, WI and WV and countries of Australia, Belgium, Canada, Japan and Singapore.
 
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