—#163824

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.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K103367
Affected lot / code info: UDI: (01)00801741067921(17)191115(10)VTBY0563, Lot Number: VTBY0563

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.

Root cause (FDA determination)

Process control

Action the firm took

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 BPV.CustomerSupportCenter@crbard.com or faxed to 1-800-994-6772.

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2018-04-16
Posted by FDA: 2018-05-11
Terminated: 2021-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163824. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.