Recall Z-2870-2016 ยท FMI Needle, Hypodermic, Single Lumen
Global Healthcare Inc
MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.
| Date | Sep 22, 2016 (initiated Aug 9, 2016) |
| Status | Terminated |
| Reason | The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 282 cartons (1000 units per carton) |
| Distribution | FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000714 | VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET Med-Pro Technologies, Inc., Dec 21, 2000 |