Recall Z-1397-2025 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
B Braun Medical Inc
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
| Date | Mar 19, 2025 (initiated Feb 17, 2025) |
| Status | Open, Classified |
| Reason | Increased risk for valve housing detachment causing leakage. |
| Root cause | Process control |
| Action | An URGENT MEDICAL DEVICE RECALL NOTIFICATION dated 2/13/25 was mailed to consignees notifying them of this product removal. Consignees are instructed to review the recall notification and to forward the notice along to those in their organization and to those to which product was further distributed. Consignees are to quarantine any affected devices in their inventory and coordinate product return by completion and return of the provided Product Recall Acknowledgement Form. Consignees with any questions are to contact B Braun at 844-903-6417. |
| Quantity | 28,200 units |
| Distribution | Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111236 | INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 B.Braun Melsungen AG, Aug 30, 2011 |
| K182870 | Introcan Safety 3 Closed IV Catheter B.Braun Medical, Inc., Mar 7, 2019 |
| K213085 | Introcan Safety 3 Closed IV Catheter B.Braun Medical, Inc., Oct 25, 2021 |