Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
FDA Recall Z-2830-2016 · Posted 2016-09-15
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Recalling FirmC.R. Bard, Inc.
Recall StatusTerminated
Product CodeEZL
Date Initiated2016-07-11
Date Terminated2017-03-22
Product Quantity274 units
Reason for Recall
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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