FDA Medical Device Recalls (openFDA)
Bard Access Systems Inc.: 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
- Recall number
- Z-1991-2021
- Recalling firm
- Bard Access Systems Inc.
- Product
- 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
- Status
- Terminated
- Initiated
- 2021-05-19
- Posted
- not on file
- Terminated
- 2023-01-24
- Reason
- Catheter kits contained the incorrect micro-introducers.
- Root cause
- Process control
- Action
- 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
- Quantity
- 180 units
- Distribution
- U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None
- Lot, serial or model codes
- Catalog Number: 3175155 UDI Code: (01)00801741027680 Lot Number: REEU0201
- 510(k) numbers
- ["K051672"]
- 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