PowerPICC Catheter recallZ-1991-2021 · Bard Access Systems Inc. · initiated May 19, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bard Access Systems Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Catheter kits contained the incorrect micro-introducers.
FDA root cause category: Process control
What the company is doing
On 05/19/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE RECALL" Notification via FedEx second day air to customer informing them that they have confirm through customer complaints that catheter kits contains the incorrect micro-introducers. Customer are instructed to: 1. Immediately review their inventory for the specific Catalog (Ref) and lot numbers and destroy all product subject to the recall following their institutions process for destruction. The Recalling Firm will replace discarded product. 2. Share this recall notification with all users within or outside their facility network to which they may have further distributed the affected products to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not they have any of the impacted material so that Recalling Firm may acknowledge the receipt of this notification per FDA requirements and subsequently process your product replacement. For any questions or further assistance - contact: North American Regional Complaint Center 1-84BD-LIFE (1-844-823-5433) Say Recall when prompted MonFri 8:00am and 5:00pm CT
Recall details
- Recall number
- Z-1991-2021
- Status
- Terminated
- Initiated by the company
- May 19, 2021
- Recalling firm
- Bard Access Systems Inc.
- Quantity
- 180 units
- Product code
- LJS
- FDA submissions
- K051672
- Distribution
- U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None
Product description
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Code information (models, lots, serial numbers)
Catalog Number: 3175155 UDI Code: (01)00801741027680 Lot Number: REEU0201
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PowerPICC Catheter 3175155Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall4 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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