Recall Z-0955-03 ยท FPA Set, Administration, Intravascular
Abbott Laboratories HPD/ADD
Vented and Non-Vented Burette I.V. Gravity Feed Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 15 different sets listed in the code information section below.
| 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 | 178,243 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
| K832755 | INFUSION PUMP & IV SETS #4000 Omni-Glow, Inc., Nov 3, 1983 |
| K913308 | IVEX-TPN EXTENSION FILTER SET Abbott Laboratories, Jan 15, 1992 |
| 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 |