MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by
FDA device recall Z-2870-2016 · posted 2016-09-22 · Terminated
Recall details
- Recalling firm
- Global Healthcare Inc
- Reason for recall
- The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.
- Action taken
- The distributors were first notified on August 9, 2016 via phone to place product on hold. They were notified of the recall on August 10, 20l6 by email.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 282 cartons (1000 units per carton)
- Distribution
- FL
- Date initiated
- 2016-08-09
- Date posted
- 2016-09-22
- Date terminated
- 2017-01-23
- Location
- Alpharetta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET (K000714) | Med-Pro Technologies, Inc. | 2000-12-21 |