ClearanceBrief
Recall Z-0083-06 ยท LHI Set, I.V. Fluid Transfer

Medrad Inc

Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT

DateOct 21, 2005 (initiated Sep 20, 2005)
StatusTerminated
Reasonstress crack on the stopcock
Root causeOther
ActionThe recalling firm issued letters dated 9/20/05 to the hospitals and sales representative informing them of the problem and the need to return the product.
Quantity850 units
DistributionThe products were shipped to medical facilities in CA, CO, DE, FL, IL, MA, NC, OH, PA, and VA. The products were also shipped to sales representatives in CA, CO, FL, MA, MN, MO, OK, PA, SC, and WI. The products were sent to the recalling firm''s distributors in the Netherlands, Denmark, France, and
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K050456MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
Medrad, Inc., Jun 17, 2005