Recall Z-0915-03 ยท FRN Pump, Infusion
Abbott Laboratories HPD/ADD
LifeShield Latex-Free Microdrip Soluset 100 mL Burette Plumset Convertible Pin, 121-1/2 Inch with CLAVE and OPTION-LOK Dual Channel Secondary Port, product 19289
| Date | Jun 5, 2003 (initiated May 13, 2003) |
| Status | Terminated |
| Reason | IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced. |
| Root cause | Other |
| Action | Recall letter dated 5/12/03 sent to the accounts on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lots to Abbott for credit. |
| Quantity | 5,680 units |
| Distribution | Nationwide. California, Colorado, Connecticut, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Montana, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin. |
| 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 |