Angiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir.
FDA device recall Z-0619-05 · posted 2005-03-15 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- Syringes could possibly allow air to enter the patient's vascular system.
- Action taken
- Consignees were notified by letter on 11/10/04 or by telephone on 11/11/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 250 syringes
- Distribution
- Domestic distribution: Nationwide, including 2 military/VA facilities. International distribution: Spain, Belgium, Greece, Japan, and France.
- Date initiated
- 2004-11-02
- Date posted
- 2005-03-15
- Date terminated
- 2005-07-25
- Location
- Lake Forest, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAND CONTROLLED SYRINGE (K942329) | Abbott Laboratories | 1994-06-20 |
| DYE MANAGEMENT SYSTEM (K933700) | Abbott Laboratories | 1993-11-03 |
| SAFESET RESERVOIR (K932188) | Abbott Laboratories | 1993-10-25 |
| TRANSPAC(R) II, DISPOSABLE TRANSDUCER (K884823) | Abbott Laboratories | 1990-07-03 |