Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
FDA device recall Z-1367-2026 · posted 2026-02-13 · Open, Classified
Recall details
- Recalling firm
- Bard Peripheral Vascular Inc
- Reason for recall
- Due to damage to outer tray that can potentially compromise the sterile barrier
- Action taken
- On 01/12/1026, the firm sent via FedEx and/or email an "URGENT: Medical Device Product Removal" Letter informing customers that BD has identified via internal inspections that the packaging of some Hickman Catheter and Broviac Catheter kits may have damage present on the outer tray, potentially compromising the sterile barrier. Affected products were distributed between 06/12/2025 to 11/28/2025. Customers are instructed to: 1. Discontinue use of product listed in the letter and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process. 2. Share this notification with all users within their facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, forward this notification to ensure that these entities are contacted and informed of the recall. 3. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not they have any of the product so that BD may acknowledge their receipt of this notification and subsequently process any required product credit. 4. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of. For questions or assistance, contact: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LJS
- Quantity affected
- 14,935 units
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH,
- Date initiated
- 2025-12-12
- Date posted
- 2026-02-13
- Location
- Tempe, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NON-STERILE BROVIAC PARENTERAL ALIMI- (K830256) | Evermed, Inc. | 1983-03-01 |
| NON-STERILE,SINGLE/SOUBLE LUMEN-CATH (K830233) | Evermed, Inc. | 1983-02-28 |