BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.
This recall has been terminated (originally issued May 11, 2018).
- Company
- Bard Peripheral Vascular Inc
- Recall Initiated
- April 16, 2018
- Posted
- May 11, 2018
- Terminated
- March 2, 2021
- Recall Number
- Z-1803-2018
- Quantity
- 130 units
- Firm Location
- Tempe, AZ
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution
Lot / Code Info
UDI: (01)00801741067907(17)191207(10)VTBZ0193, Lot Number: VTBZ0193
Root Cause
Process control
Action Taken
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.