PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lu
FDA device recall Z-1525-2010 · posted 2010-04-29 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- 8F PowerPort stems were mixed with 6F PowerPorts and packaged.
- Action taken
- The firm, Bard Access Systems, Inc. (BAS) sent a "URGENT: Powerport isp M.R.I with 6F Chronoflex Catheter RECALL" letter dated March 18, 2010, to the customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to immediately examine their inventory and quarantine all products subject to this recall and notify any customers they may have distributed the product to; DO NOT USE THIS PRODUCT OR FURTHER DISTRIBUTE ANY OF THE IMPLICATED LOTS; remove and return the affected lots to BAS, and complete and Fax the Reply Form and Inventory Reconciliation Form, if unable to Fax call and report information. Only unused products, in its original packaging, should be returned to BAS. Should you have any questions or require assistance in this matter, please contact BAS Customer Service by calling our toll-free number 1-800-290-1689.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 200 units total (100 units of each lot, see code information)
- Distribution
- Nationwide distribution: AZ, CA, DC, FL, MA, MD, NC, NE, NV, NY, PA and SC.
- Date initiated
- 2010-03-18
- Date posted
- 2010-04-29
- Date terminated
- 2010-10-01
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER (K072549) | C.R. Bard, Inc. | 2007-11-14 |