Recall Z-3030-2017 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.
| Date | Jun 30, 2017 |
| Status | Terminated |
| Reason | Punctures in blister packaging that was detected during the packaging process. |
| Root cause | Packaging process control |
| Action | BD sent an Urgent Medical Device Recall letter dated June 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use and return the affected lot to CareFusion for replacement. For recall related questions contact BD Support Center 1-888-562-6018. |
| Quantity | 1,546,800 units |
| Distribution | Worldwide Distribution in the states of : CO, IL, IN, MD, MI, NY, OH, & TX. and foreign countries of: Australia, New Zealand, & Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945070 | VERSASAE PLASTIC CANNULA- 11 GAUGE Imed Corp., Jan 13, 1995 |