Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in
FDA device recall Z-0936-03 · posted 2003-06-17 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD
- Reason for recall
- The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL
- Action taken
- Recall letter dated 5/12/03 sent to the account on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lot to Abbott for credit.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 4,656 units
- Distribution
- Miami, FL
- Date initiated
- 2003-05-13
- Date posted
- 2003-06-17
- 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 |
|---|---|---|
| LIFESHIELD EXTENSION SET (K941214) | Abbott Mfg., Inc. | 1994-10-03 |
| I.V. SET WITH DUAL-CHANNEL CASSETTE (K865060) | Abbott Laboratories | 1987-02-06 |
| INFUSION PUMP & IV SETS #4000 (K832755) | Omni-Glow, Inc. | 1983-11-03 |
| IV EXTENSION SET SL (K791930) | Abbott Laboratories | 1979-10-26 |