Recall Z-0956-03 · FPA Set, Administration, Intravascular

Abbott Laboratories HPD/ADD

I.V. Extension Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 22 different sets listed in the code information section below. Please Note: items p, q & r (list 191700204, 191700404 and 191700415) were packaged in kits with Sporanox Injection distributed by Ortho Biotech Products, Raritan, NJ 08869.

Date	Jun 27, 2003 (initiated Jun 9, 2003)
Status	Terminated
Reason	The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
Root cause	Other
Action	The IV administration sets were recalled by letters dated 6/9/03, advising the accounts of the discoloration of the sight chamber and adapters due to the use of non-radiation grade plastic resin in the manufacture of these components of the sets and requesting the return of the sets for credit. These letters were accompanied by a customer ship history/business reply form, which listed the specific set list numbers and lot numbers shipped to the direct account. The direct accounts were requested to send copies of the enclosed recall letter with the listing of all affected sets to their subacc
Quantity	3,667,374 sets
Distribution	Nationwide and Internationally to Abbott affiliates in Argentina, Aruba, Australia, the Bahamas, Barbados, Bermuda, Bolivia, Brazil, Canada, Cayman Islands, Chile, Columbia, Costa Rica, Croatia, Curacao, Dominican Republic, Ecuador, Egypt, El Salvador, France, Greece, Guam, Guatemala, Haiti, Hondura
FDA record	Open on fda.gov

510(k) clearances named in this recall

K915571	CLAVE CONNECTOR Icu Medical, Inc., Sep 21, 1992
K920736	IVEX-HP96 EXTENDED LIFE FILTER SET Abbott Laboratories, Apr 23, 1993
K941214	LIFESHIELD EXTENSION SET Abbott Mfg., Inc., Oct 3, 1994
K970855	CLAVE CONNECTOR Icu Medical, Inc., Jun 24, 1997
K991932	INTRAVASCULAR ADMINISTRATION SET The Kipp Group, Aug 20, 1999