PowerPICC recallZ-1994-2021 · Bard Access Systems Inc. · initiated May 19, 2021
Class II 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 convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
FDA root cause category: Process control
What the company is doing
On 05/19/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE CORRECTION" Notification via FedEx 2-day to customers informing them that the Recalling Firm has confirmed through customer complaint that a number of catheter convenience kits labeled as having 70cm guidewires may actually contain 50cm guidewires. The Recalling Firm is providing customers with a quick way of identifying if their kit contains the correct or incorrect size guidewire by determining the number of loops of the wire. Customers are instructed to: 1. Immediately review their inventory for the specific Catalog (Ref) and lot numbers listed. Determine if the product has the correct product based on the number of loops of the guidewire while the product is still in the packaging material. Product may be discarded when clinically necessary and replacement requested. 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 these additional users are also aware of this advisory notice. 3. Complete the attached Customer Response Form and return to the Recalling Firm contact noted on the form whether or not they have any of the impacted material so that Recalling Firm may acknowledge receipt of this notification per FDA requirements and subsequently process the product replacement, if necessary. For further assistance or for questions - 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-1994-2021
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 19, 2021
- Recalling firm
- Bard Access Systems Inc.
- Quantity
- 30 kits
- Product code
- LJS
- Distribution
- U.S. Nationwide distribution in the state of RI.
Product description
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
Code information (models, lots, serial numbers)
Catalog (REF) Number: CK000340B UDI Code: (01)00801741126697 Lot Number: 20BBK658
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PowerPICC CK000340BBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall0 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 18, 2026. Text above is shown as published by the FDA.
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