Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identifie
FDA device recall Z-0802-06 · posted 2006-04-27 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- Reason for recall
- One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT systems. The packaged Wand-Cover is placed on the outside of the PORT-A-CATH II AND P.A.S. PORT tray.
- Action taken
- An Urgent Product Safety & Recall Notification, dated 03/29/06, was mailed to domestic customers and emailed to international customers. The letter described the issue, identified re-order number and lot numbers affected and gave 3 options. The options include to use only the sterile tray and discard the wand cover from the shelf box; remove and discard Locator-Wand Cover pouches and request replacement Locator-Wand Covers; or return the entire device for a credit or replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- MMP
- Quantity affected
- 181 trays
- Distribution
- Nationwide. AR, CA, DE, FL, IL, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OK, PA, TN, TX, VA, WI. Germany, Italy, Netherlands, Singapore, Spain
- Date initiated
- 2006-03-29
- Date posted
- 2006-04-27
- Date terminated
- 2007-01-23
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM (K942024) | Pharmacia Deltec, Inc. | 1994-07-26 |