Bard Peripheral Vascular Inc: 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.

Recall number

Z-1529-2013

Recalling firm

Bard Peripheral Vascular Inc

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.

Status

Terminated

Initiated

2013-01-23

Posted

2013-06-10

Terminated

2013-06-10

Reason

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).

Root cause

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

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.

Lot, serial or model codes

PC USH07AT; Lot# FCWC10009

510(k) numbers

["K090547"]

PMA numbers

not on file

Product code

DQY

Firm FEI

2020394

Firm city

Tempe

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy