Recalls / —

—#148278

Product

Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.

FDA product code

EZL — Catheter, Retention Type, Balloon

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K023090

Affected lot / code info

Device Listing No.: D022512. CatalogNo.: FV14218. Lot No.: P1007637, P1007638, P1007461. Exp Date: 08/01/2016.

Why it was recalled

During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.

Root cause (FDA determination)

Device Design

Action the firm took

C.R. Bard sent an Urgent - Medical Device Product Recall letter dated July 8, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm notifies customers of the recall, provides a clinical risk statement, and gives instructions regarding product disposition. Facilities are instructed to examine their inventory and quarantine any recalled product. The firm requested that customers complete the Recall & Effectiveness Check Form if product is or is not in inventory. If product was further distributed, customers should be forwarded the recall notification letter and Recall& Effectiveness Check Form. If you or the patient using these catheters has had an adverse event related to the recalled catheters, please contact Bard Medical Division Field Assurance at 1-800-526-4455 (option 5, then option 4) or via email at BMD.FieldAssurance@crbard. com.

Recalling firm

Firm

C.R. Bard, Inc.

Address

8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

Distribution pattern

US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.

Timeline

Recall initiated

2016-07-11

Posted by FDA

2016-09-15

Terminated

2017-03-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #148278. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.