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U.S. Department of Health and Human Services

Class 2 Device Recall USHER Support Catheter Angled Tip WL130cm

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 Class 2 Recall
USHER Support Catheter Angled Tip WL130cm
see related information
Date Posted June 10, 2013
Recall Status1 Terminated on June 10, 2013
Recall Number Z-1529-2013
Recall Event ID 64276
Premarket Notification
510(K) Number
K090547 
Product Classification Catheter, Percutaneous - Product Code DQY
Product USHER® Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085. The Usher® Peripheral is a single lumen support catheter, with a standard luer fitting at the proximal end. The Usher® Peripheral is available in a length 130 cm with an angled tip shape.
Code Information PC USH07AT; Lot# FCWC10009
Recalling Firm/
Manufacturer
Bard Peripheral Vascular Inc
1625 W 3rd St Ste 109
Tempe, Arizona 85281-2438
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Chad Modra
480-303-2602
Manufacturer Reason
for Recall
Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The firm, BARD Peripheral Vascular, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter on January 23, 2013, to its customers. Bard EXPANDED its recall to include (MicroSheath and Usher support Catheters) and sent another "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated March 5, 2013 describing the additional products, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed as follows: Do not use or further distribute any affected product; check all inventory locations within your institution; remove any identified product from your shelves and return to Bard Peripheral Vascular, Inc. 1415 W. 3rd Street, Tempe, AZ 85281; if you have further distributed any of the product, immediately contact that location and advise them of the recall and have them return to BPV; If you have used the affected product, consider notifying, educating and monitoring those affected; and complete and return the Recall and Effectiveness Check form via fax to: ATTN; Recall Coordinator in Customer Service at 1-800-994-6772, even if you no longer have possession of the product; if unable to FAX call BPV at 1-800-321-4254 Option #2 Ex 2727 and report verbally. Please call our Recall Coordinator at 1-800-321-4254 Option #2 Ext 2727 (M-F 7am to 4pm MST) or email at HUsilvia.carrillo@crbard.com with any questions.
Quantity in Commerce 223
Distribution Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = C.R. BARD, INC.
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