—#73817

Product

Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units per carton.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K955585
Affected lot / code info: Item number 474515. Lot number 0061014615 exp 6/30/2013

Why it was recalled

Product was assembled incorrectly and connected to the wrong part.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Nationwide Distribution --- including states of CA, FL, NC, NJ, and TX.

Timeline

Recall initiated: 2008-09-17
Posted by FDA: 2008-10-24
Terminated: 2009-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.