Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identifie
FDA device recall Z-0064-2007 · posted 2006-10-24 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- Reason for recall
- Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are supplied on the outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an insufficient seal and product sterility could be compromised.
- Action taken
- An Urgent Product Safety & Recall Notification, dated 09/27/06, was sent to customers via facsimile and phone calls were made. The letter describes the issue and customers are given 3 options to include: use only the sterile tray and discard the wand cover, 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
- 2 trays
- Distribution
- CA, FL, MA, MD, OH, OK, TX
- Date initiated
- 2006-09-27
- Date posted
- 2006-10-24
- Date terminated
- 2006-12-30
- 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 |