Seeker recallZ-1802-2018 · Bard Peripheral Vascular Inc · initiated Apr 16, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bard Peripheral Vascular Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1802-2018
- Status
- Terminated
- Initiated by the company
- Apr 16, 2018
- Posted by the FDA
- May 11, 2018
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 140 units
- Product code
- DQY
- FDA submissions
- K103367
- Distribution
- Nationwide Distribution
Product description
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.
Code information (models, lots, serial numbers)
UDI: (01)00801741067921(17)191115(10)VTBY0563, Lot Number: VTBY0563
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Seeker® SK15035MBard Peripheral Vascular, Inc. · CATHETER, PERCUTANEOUS1 recall9 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 79896).
- Z-1803-2018 · TerminatedBARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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