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U.S. Department of Health and Human Services

Class 2 Device Recall HandiFil Disposable Syringe Fill Tube

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  Class 2 Device Recall HandiFil Disposable Syringe Fill Tube see related information
Date Initiated by Firm December 20, 2011
Date Posted January 19, 2012
Recall Status1 Terminated 3 on February 19, 2013
Recall Number Z-0815-2012
Recall Event ID 60897
510(K)Number K781334  
Product Classification Injector and syringe, angiographic - Product Code DXT
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 OH 45237-1624
For Additional Information Contact
513-948-5719
Manufacturer Reason
for Recall		 The firm received complaints from their customers stating that they found open seals on two of their sterilized products.
FDA Determined
Cause 2		 Packaging
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = MALLINCKRODT GROUP, INC.
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