Recall Z-2081-2012
Mallinckrodt Inc · initiated February 1, 2010
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot #7159027 / Catalog #302050
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: Packaging process control
Action taken
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.
Details
- Recall number
- Z-2081-2012
- Initiated
- February 1, 2010
- Posted by FDA
- July 26, 2012
- Terminated
- August 3, 2012
- Product code
- DXT – Injector And Syringe, Angiographic
- Quantity
- 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.
- Recalling firm
- Mallinckrodt Inc, Cincinnati, OH