Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.

FDA device recall Z-2831-2016 · posted 2016-09-15 · Terminated

Recall details

Recalling firm

C.R. Bard, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

EZL

Quantity affected

274 units

Distribution

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

Date initiated

2016-07-11

Date posted

2016-09-15

Date terminated

2017-03-22

Location

Covington, GA

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