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U.S. Department of Health and Human Services

Class 2 Device Recall SEEKER(R) Crossing Support Catheter

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  Class 2 Device Recall SEEKER(R) Crossing Support Catheter see related information
Date Initiated by Firm April 16, 2018
Date Posted May 11, 2018
Recall Status1 Terminated 3 on March 02, 2021
Recall Number Z-1802-2018
Recall Event ID 79896
510(K)Number K103367  
Product Classification Catheter, percutaneous - Product Code DQY
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.
Code Information UDI: (01)00801741067921(17)191115(10)VTBY0563, Lot Number: VTBY0563
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
Manufacturer 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.
FDA Determined
Cause 2		 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 BPV.CustomerSupportCenter@crbard.com or faxed to 1-800-994-6772.
Quantity in Commerce 140 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = BARD PERIPHERAL VASCULAR, INC.
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