Z-1802-2018Class II

BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to...

Name: Z-1802-2018 BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to...
Creator: Bard Peripheral Vascular Inc
Published: 2018-04-16
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2018-04-16 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature on 2018-04-16. FDA classified it as Class II and gives the reason as "Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels...". 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-1802-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-16
Posted: 2018-05-11
Terminated: 2021-03-02
Recalling firm: Bard Peripheral Vascular Inc
Product: BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.
Product code: DQY Catheter, Percutaneous
Reason for recall: Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall via an Urgent Medical Device Recall Notification letter on 04/16/2018. The letter identified the affected device, reason for the recall, and required actions. Customers are asked to check their inventory for and remove the affected product code and lot number combinations. The Recall and Effectiveness Check Form should be completed and returned even if affected product has been used. The firm requested the return of the recalled product; and will provide a replacement after all information has been verified and product returned. The completed form can be emailed to [email protected] or faxed to 1-800-994-6772.
Quantity in commerce: 140 units
Distribution: Nationwide Distribution
Product codes and lots: UDI: (01)00801741067921(17)191115(10)VTBY0563, Lot Number: VTBY0563

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1802-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1802-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-11
Z-1803-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-11

Product code DQY

K103367Class IISeeker Crossing Support CatheterBard Peripheral Vascular, Inc. / cleared 2010-12-08

MDM coverage of this record lists here, newest first.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)