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 Recall Z-0199-2009 · Posted 2008-10-24
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Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2008-09-17
Date Terminated2009-05-05
Product Quantity3900 units
Reason for Recall
Product was assembled incorrectly and connected to the wrong part.
Firm Action
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
Distribution Pattern
Nationwide Distribution --- including states of CA, FL, NC, NJ, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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