Catheterization Kits containing Angiographic Syringes with rotator connector.
FDA device recall Z-0621-05 · 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
- 62080 kits
- 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 |
|---|---|---|
| CARDIAC CATHETERIZATION KIT (K932141) | Abbott Laboratories | 1994-09-22 |