Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Pr
FDA device recall Z-1639-2010 · posted 2010-05-21 · Terminated
Recall details
- Recalling firm
- Churchill Medical Systems, Inc.
- Reason for recall
- Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents
- Action taken
- Churchill Medical Systems issued an "Urgent: Product Advisory Customer Notification" dated October 20, 2009 requesting return of affected product and notification to end users. For further information, contact Churchill Medical Systems at 1-603-743-5988 or via fax at 1-603-743-6328.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 283,900 each
- Distribution
- Distributed to Florida.
- Date initiated
- 2009-10-20
- Date posted
- 2010-05-21
- Date terminated
- 2013-03-28
- Location
- Dover, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK (K011336) | Churchill Medical Systems, Inc. | 2001-06-12 |