Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
FDA device recall Z-1397-2025 · posted 2025-03-19 · Open, Classified
Recall details
- Recalling firm
- B Braun Medical Inc
- Reason for recall
- Increased risk for valve housing detachment causing leakage.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FOZ
- Quantity affected
- 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.
- Date initiated
- 2025-02-17
- Date posted
- 2025-03-19
- Location
- Bethlehem, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Introcan Safety 3 Closed IV Catheter (K213085) | B.Braun Medical, Inc. | 2021-10-25 |
| Introcan Safety 3 Closed IV Catheter (K182870) | B.Braun Medical, Inc. | 2019-03-07 |
| 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 (K111236) | B.Braun Melsungen AG | 2011-08-30 |