Enforcement Report - Week of August 1, 2012
-
Back to Previous Page
Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-2081-2012 |
| Classification | Class II |
| Code Info | Lot #7159027 / Catalog #302050 |
| Product Distributed Qty | 75 cases (100 units per case) |
| 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. |
Event Detail
| Event Id | 54724 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Mallinckrodt Inc |
| City | Cincinnati |
| State | OH | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2010-02-01 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 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. |
-
