Recall Z-2081-2012 ยท DXT Injector And Syringe, Angiographic
Mallinckrodt Inc
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.
| Date | Jul 26, 2012 (initiated Feb 1, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 c |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K781334 | DISPOSABLE SYRINGE FILL TUBE Mallinckrodt Group, Inc., Aug 17, 1978 |