LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE P
FDA device recall Z-0914-03 · posted 2003-06-05 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD
- Reason for recall
- IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 7,160 units
- Distribution
- Nationwide. California, Colorado, Connecticut, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Montana, New Hampshire, New Jersey, New York, Oregon, Pennsyl
- Date initiated
- 2003-05-13
- Date posted
- 2003-06-05
- Date terminated
- 2003-11-20
- Location
- Abbott Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRAVASCULAR ADMINISTRATION SET (K991932) | The Kipp Group | 1999-08-20 |
| CLAVE CONNECTOR (K915571) | Icu Medical, Inc. | 1992-09-21 |
| IV EXTENSION SET SL (K791930) | Abbott Laboratories | 1979-10-26 |