Recall Z-0509-2021 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Janus Trade Group
B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01
| Date | Nov 30, 2020 (initiated Mar 23, 2020) |
| Status | Terminated |
| Reason | Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG. |
| Root cause | No Marketing Application |
| Action | Between March 13-25, 2020, Janus Trade Group made phone contact with customers requesting to check if customers had product on hand. If customers had product on hand, they were asked to send it back to JTG for a full refund. |
| Quantity | 1365 cases (200 units/case) |
| Distribution | US distribution to distributors located in CA, FL, IL, KS, NJ, NY, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.