Z-1991-2021Class II

5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand...

Name: Z-1991-2021 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand...
Creator: Bard Access Systems Inc.
Published: 2021-05-19
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2021-05-19 / Terminated / root cause: manufacturing process

FDA source

Bard Access Systems Inc. began a recall of 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer on 2021-05-19. FDA classified it as Class II and gives the reason as "Catheter kits contained the incorrect micro-introducers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1991-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-19
Posted: 2021-06-30
Terminated: 2023-01-24
Recalling firm: Bard Access Systems, Inc.
Product: 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Catheter kits contained the incorrect micro-introducers.
Root cause tag: manufacturing process
FDA 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 in commerce: 180 units
Distribution: U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None
Product codes and lots: Catalog Number: 3175155 UDI Code: (01)00801741027680 Lot Number: REEU0201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1991-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1991-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-30

Product code LJS

K051672Class IIPowerpiccBard Access Systems, Inc. / cleared 2005-11-23

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)