Recall Z-0957-03 ยท FPA Set, Administration, Intravascular
Abbott Laboratories HPD/ADD
Primary I.V. Gravity Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 95 different sets listed in the code information section below. Please note, item k, list 018810458, lot 910824W, was also case packed with Liposyn II 20%, list 09793-04-03, lot 94533DF and list 09792-04-02, lot 92522DF, distributed by Abbott Laboratories, North Chicago, IL
| 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 | 18,560,003 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
| K770518 | PIGGYBACK VENOSET W/0.22 FILTER Abbott Laboratories, Apr 29, 1977 |
| K832755 | INFUSION PUMP & IV SETS #4000 Omni-Glow, Inc., Nov 3, 1983 |
| K833741 | VENOSET MULTI MED DUAL RATE PIGGYBACK Abbott Laboratories, Dec 22, 1983 |
| K920736 | IVEX-HP96 EXTENDED LIFE FILTER SET Abbott Laboratories, Apr 23, 1993 |
| K971293 | LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE Abbott Mfg., Inc., Jun 27, 1997 |