FDA Recall
Terminated
Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.
Recall: Z-2407-2008
·
Initiated June 30, 2008
Recall
- Recall Number
- Z-2407-2008
- Event Number
- 49078
- Firm
- B. Braun Medical, Inc.
- FEI Number
- 2523676
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- June 30, 2008
- Posted
- September 23, 2008
- Terminated
- May 5, 2009
- Address
- 901 Marcon Boulevard, Allentown, PA, 18109-9512
Description
Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.
Reason
incorrect burette was packaged with the product
Action
The firm issued a Product Removal Notice dated 6/20/08 via USPS Certified Mail with registered receipt mail to all customers in receipt of affected product. The notice informs customers of the problem, to cease use and distribution immediately, and to return the product. Contact B. Braun Medical at 1-800-227-2862 for assistance.
Distribution
Nationwide.
Quantity
13,360 units