Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5
FDA device recall Z-0199-2009 · posted 2008-10-24 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Product was assembled incorrectly and connected to the wrong part.
- Action taken
- The recalling firm issued an Urgent - Medical Device Recall letter dated 9/17/08 to the distributors informing them of the problem and the need to return the product. The letter states that further distribution of the product should be immediately discontinued. Utilizing the "Product Removal Acknowledgement" form, customers should combine their inventory with the inventories reported by their customers and record them on the form. If affected products and associated lot numbers are currently in their possession, customers should call Customer Support Department to arrange for shipping and replacement product. A Customer Support Rep will provide instructions for handling affected product.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 3900 units
- Distribution
- Nationwide Distribution --- including states of CA, FL, NC, NJ, and TX.
- Date initiated
- 2008-09-17
- Date posted
- 2008-10-24
- Date terminated
- 2009-05-05
- Location
- Allentown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| V2 INJECTION SITE (K955585) | B.Braun Medical, Inc. | 1996-05-15 |