LifeShield Latex-Free Microdrip Soluset 100 mL Burette Plumset Convertible Pin, 121-1/2 Inch with CLAVE and OPTION-LOK D
FDA device recall Z-0915-03 · 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
- FRN
- Quantity affected
- 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, 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 |
|---|---|---|
| INFUSION PUMP & IV SETS #4000 (K832755) | Omni-Glow, Inc. | 1983-11-03 |