Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. Intended for

FDA device recall Z-0719-2011 · posted 2010-12-21 · Terminated

Recall details

Recalling firm

C.R. Bard, Inc., Urological Division

Reason for recall

Error can occur in the reading of the Present Interval Output (PIO) reading when the device is subjected to bumping or forceful replacement of the fluid container.

Action taken

Consignees were notified by an Urgent: Product Advisory Letter and Medica Device Recall letter on/about November 18, 2010. The letter identified the affected product, stated the reason for recall, the interim precautions, and actions to be taken. The letter requested acknowledgement of the recall and to return the entire affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. Affected product received by Bard Medical will be reworked with the software upgrade and place back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. For international distribution, the hospital will be informed of this issue through Bard affiliate and Notified Body Bard Europe and managed according to the requirement. If there are questions or assistance is needed, customers can contact BD at 1-770-784-6969.

Root cause

Other

Status

Terminated

Product code

EXS

Quantity affected

234 units

Distribution

Worldwide Distribution -- U.S., Netherlands, and Japan.

Date initiated

2010-11-17

Date posted

2010-12-21

Date terminated

2012-02-02

Location

Covington, GA