| Class 2 Device Recall HandiFil Disposable Syringe Fill Tube | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DXT
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