Events

Recall of Ultrasite Horizon Pump IV Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by B. Braun Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37856
  • Event Risk Class
    Class 2
  • Event Number
    Z-0818-2007
  • Event Initiated Date
    2007-04-18
  • Event Date Posted
    2007-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51961
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    IV Set - Product Code FPA
  • Reason
    Secondary infusion backs up into primary container.
  • Action
    The recalling firm issued Product Removal Notices on 4/20/07 via certified priority mail. The notice informed the customer of the problem and the need to return the product.

Device

Ultrasite Horizon Pump IV Set
  • Model / Serial
    Lot numbers: 60883411 exp 9/09, 60886994 exp 9/09, 60883415 exp 9/09, 60883413 exp 9/09, 60883414 exp 9/09, 60883412 exp 9/09, 60883411 exp 9/09, 60883409 exp 9/09, 60883408 exp 9/09, 60883406 exp 9/09, 60883403 exp 9/09, 60884052 exp 9/09, 60884051 exp 9/09, 60883404 exp 9/09, 60883401 exp 8/09, 60883402 exp 8/09, 60883400 exp 8/09, 60883399 exp 8/09, 60883396 exp 8/09, 60883397 exp 8/09, 60883398 exp 8/09, 60880087 exp 8/09, 60880088 exp 8/09, 60880086 exp 8/09, 60880085 exp 8/09, 60880084 exp 8/09, 60880083 exp 8/09, 60880082 exp 8/09, 60880081 exp 8/09, 60880080 exp 8/09, 60880079 exp 8/09, 60880077 exp 8/09, 60880076 exp 8/09, 60880078 exp 8/09, 60880075 exp 8/09, 60880073 exp 8/09, 60880074 exp 8/09, 60875352 exp 7/09, 60875353 exp 7/09,60875350 exp 7/09, 60875348 exp 7/09, 60875349 exp 7/09, 60875347 exp 7/09, 60876056 exp 7/09, 60875345 exp 7/09, 60875346 exp 7/09, 60875344 exp 7/09, 60875343 exp 7/09, 60875342 exp 7/09, 60873263 exp 7/09, 60873262 exp 7/09, 60873260 exp 7/09, 60873261 exp 7/09, 60871825 exp 6/09, 60871439 exp 6/09, 60871824 exp 6/09, 60871823 exp 6/09, 60871438 exp 6/09, 60871437 exp 6/09, 60871436 exp 6/09, 60871435 exp 6/09, 60871434 exp 6/09, 60871433 exp 6/09, 60871431 exp 6/09, 60871432 exp 6/09, 60871430 exp 6/09, 60878152 exp 6/09, 60871429 exp 6/09, 60869484 exp 6/09, 60869482 exp 6/09, 60869479 exp 6/09, 60861428 exp 6/09, 60869467 exp 6/09, 60869466 exp 6/09, 60861993 exp 5/09, 60861995 exp 5/09, 60861996 exp 5/09, 00VL861992 exp 5/09, 00VL861991 exp 5/09, 00VL861990 exp 5/09, 60872855 exp 5/09, 60861985 exp 4/09, 60872856 exp 5/09, 60872854 exp 5/09, 60861989 exp 5/09 60861987 exp 5/09, 60859835 exp 5/09, 60861986 exp 5/09, 60859834 exp 5/09, 60859832 exp 5/09, 60859831 exp 5/09, 60859830 exp 5/09, 60872648 exp 5/09, 60872649 exp 5/09, 60859829 exp 5/09, 60880072 exp 8/09, 60880071 exp 8/09, 60880070 exp 8/09, 60880069 exp 7/09, 60875361 exp 7/09, 60875359 exp 7/09, 60875360 exp 7/09, 60875358 exp 7/09, 60875357 exp 7/09, 60875354 exp 7/09, 60875351 exp 7/09, 60869478 exp 6/09, 60869480 exp 6/09, 60869477 exp 6/09, 60869474 exp 6/09, 60869472 exp 6/09, 60869475 exp 6/09, 60872863 exp 6/09, 60869473 exp 6/09, 60869471 exp 6/09, 60869470 exp 6/09, 60869468 exp 6/09, 60883303 exp 9/09, 60883302 exp 9/09, 60883300 exp 9/09, 60883296 exp 9/09, 60892342 exp 9/09, 60892341 exp 9/09, 60892340 exp 8/09, 60894050 exp 8/09, 60892339 exp 8/09, 60894049 exp 8/09, 60883293 exp 8/09, 60883294 exp 8/09, 60880023 exp 8/09, 60880022 exp 8/09, 60891081 exp 8/09, 60891082 exp 8/09, 60891080 exp 8/09, 60880021 exp 8/09, 60878211 exp 8/09, 60878210 exp 8/09, 60889215 exp 8/09, 60878209 exp 8/09, 60878207 exp 8/09, 60878206 exp 8/09, 60888274 exp 7/09, 60878205 exp 7/09, 60878201 exp 7/09, 60886694 exp 7/09, 60886695 exp 7/09, 60878200 exp 7/09, 60875237 exp 7/09, 60875236 exp 7/09, 60875234 exp 7/09, 60875235 exp 7/09, 60883723 exp 7/09, 60873265 exp 7/09, 60875233 exp 7/09, 60873264 exp 7/09, 60869494 exp 6/09, 60869495 exp 6/09, 60869493 exp 6/09, 60882489 exp 6/09, 60869491 exp 6/09, 60869489 exp 6/09, 60869488 exp 6/09, 60862067 exp 6/09, 60877549 exp 6/09, 60862066 exp 6/09, 60862065 exp 6/09, 60861761 exp 6/09, 60861760 exp 6/09, 60870771 exp 6/09, 60861759 exp 6/09, 60862063 exp 6/09, 60862064 exp 6/09, 60861758 exp 6/09, and 60861757 exp 5/09.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Ultrasite Horizon Pump IV Set. The product is shipped in cases containing 24 sets.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Manufacturer Address
    B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown PA 18109-9512
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA