Z-1994-2021Class II

5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF...

Name: Z-1994-2021 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF...
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 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... on 2021-05-19. FDA classified it as Class II and gives the reason as "Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire". 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-1994-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-19
Posted: 2021-07-01
Terminated: 2023-03-31
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
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
Root cause tag: manufacturing process
FDA 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 in commerce: 30 kits
Distribution: U.S. Nationwide distribution in the state of RI.
Product codes and lots: Catalog (REF) Number: CK000340B UDI Code: (01)00801741126697 Lot Number: 20BBK658

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1994-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1994-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-07-01

Product code LJS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)