FDA Medical Device Recalls (openFDA)
Bard Access Systems Inc.: 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
- Recall number
- Z-1994-2021
- Recalling firm
- Bard Access Systems Inc.
- Product
- 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
- Status
- Terminated
- Initiated
- 2021-05-19
- Posted
- not on file
- Terminated
- 2023-03-31
- Reason
- Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
- Root cause
- Process control
- Action
- 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
- Quantity
- 30 kits
- Distribution
- U.S. Nationwide distribution in the state of RI.
- Lot, serial or model codes
- Catalog (REF) Number: CK000340B UDI Code: (01)00801741126697 Lot Number: 20BBK658
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 3006260740
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28