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U.S. Department of Health and Human Services

Class 2 Device Recall P/N 302050 HANDI FIL DISPOSABLE SYRINGE FILL TUBE

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  Class 2 Device Recall P/N 302050 HANDI FIL DISPOSABLE SYRINGE FILL TUBE see related information
Date Initiated by Firm February 01, 2010
Date Posted July 26, 2012
Recall Status1 Terminated 3 on August 03, 2012
Recall Number Z-2081-2012
Recall Event ID 54724
510(K)Number K781334  
Product Classification Injector and syringe, angiographic - Product Code DXT
Product The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that 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 Lot #7159027 / Catalog #302050
Recalling Firm/
Manufacturer		 Mallinckrodt Inc
2111 E Galbraith Rd
Cincinnati OH 45237-1624
For Additional Information Contact Dirk E. Stevens, Ph.D.
513-948-5719
Manufacturer Reason
for Recall		 A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that ten packages of Handi Fil were not sealed.
FDA Determined
Cause 2		 Packaging process control
Action Covidien send an Urgent Device Recall letter dated February 1, 2010, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product and discontinue use of the product immediately. Customers were asked to complete the attached business form and report the quantity of affected product currently in their stock. Once the form is completed customers should fax the form to 314-654-8206. Once the business notification form is received, an RGA number will be sent to the customer for return of the product. Customers will receive credit for all returned product. For questions regarding this recall call the Product Monitoring Department at 800-778-7898. For questions about credit for the product, please call Customer Service at 888-774-1414, menu option 1, then menu option 2. For questions regarding this recall call 513-948-5719.
Quantity in Commerce 75 cases (100 units per case)
Distribution Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, GA, IL, KS, KY, LA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, & WV and countries including: AUSTRALIA, BELGIUM, BRAZIL, CANADA, JAPAN & 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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