BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118

FDA device recall Z-1507-2025 · posted 2025-04-16 · Open, Classified

Recall details

Recalling firm

Bard Access Systems, Inc.

Reason for recall

Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

Action taken

On 3/11/2025, recall notices were distributed to customers and distributors who were asked to do the following: Actions if catheter damage is suspected: 1. Stop any infusion if catheter damage is suspected. 2. Follow your institution's guidelines for catheters with suspected damage. 3. If catheter fracture is confirmed, catheter should be removed and an alternative route for access should be obtained. 4. Report any catheter replacements due to leakage to firm's Complaint Center. Please Take the Following Actions: 1. Destroy all unused product following your institution's process for destruction. 2. If affected device was previously used on a patient without incident, no further action is necessary. 3. Recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. 4. Complete and return Customer Response Form via email to Email: BDRC44@BD.com Distributors asked to identify all customers within distribution network that purchased any affected product. Provide a copy of the attached customer letter to all customers to advise them of this recall Actions Taken by Firm: 2. Firm is notifying users that adhesive-backed securement systems are recommended. 3. Firm is notifying users that if they do use compression-style securement systems, they must be sized appropriately to accommodate the taper region. 4. Firm has been updating the product IFU with cautions related to the use of compression-style securement systems around the taper region of the PICC. 5. Firm is notifying customers to insert the catheter as close as possible to the zero mark per the IFU. For further assistance, contact: North American Regional Complaint Center: 1-844-823-5433 Mon-Fri 8:00am and 5:00pm CT or productcomplaints@bd.com. On 5/15/2025 additional recall notices were distributed to customers informing them of additional affected devices.

Root cause

Process control

Status

Open, Classified

Product code

LJS

Quantity affected

718,461

Distribution

Worldwide - US Nationwide distribution including in the states of WI, NC, TX, NY, CA, MN, MT, RI, MA, OH, CT, SC, IL, CO, VA, NJ, GA, UT, FL, PA, IN, MD, KY, AZ, MI, WA, HI, MO, VT, AL, NM, TN, DE, LA

Date initiated

2025-03-11

Date posted

2025-04-16

Location

Salt Lake City, UT

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