FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc., Urological Division: Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter
- Recall number
- Z-0719-2011
- Recalling firm
- C.R. Bard, Inc., Urological Division
- Product
- Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter
- Status
- Terminated
- Initiated
- 2010-11-17
- Posted
- 2010-12-21
- Terminated
- 2012-02-02
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 234 units
- Distribution
- Worldwide Distribution -- U.S., Netherlands, and Japan.
- Lot, serial or model codes
- Catalog number 000002N, Serial numbers: DYTA0001, DYTA0002, DYTA0003, DYTA0007, DYTA0008, DYTA0011, DYTA0012, DYTA0015, DYTA0016, DYTA0017, DYTA0018, DYTA0019, DYTA0020, DYTA0021, DYTA0022, DYTA0024, DYTA0025, DYTA0027, DYTA0028, DYTA0029, DYTA0030, DYTA0031, DYTA0032, DYTA0033, DYTA0034, DYTA0036, DYTA0037, DYTA0038, DYTA0039, DYTA0040, DYTA0041, DYTA0042, DYTA0043, DYTA0044, DYTA0045, DYTA0046, DYTA0047, DYTA0049, DYTA0050, DYTA0051, DYTA0052, DYTA0053, DYTA0054, DYTA0056, DYTA0057, DYTA0058, DYTA0059, DYTA0060, DYTB0001, DYTB0003, DYTB0004, DYTB0005, DYTB0009, DYTB0010, DYTB0011, DYTB0012, DYTB0013, DYTB0015, DYTB0016, DYTB0020, DYTB0021, DYTB0022, DYTB0023, DYTB0024, DYTB0025, DYTB0026, DYTB0027, DYTB0029, DYTB0030, DYTB0031, DYTB0033, DYTB0038, DYTC0001, DYTC0004, DYTC0010, DYTC0011, DYTC0016, DYTC0017, DYTC0018, DYTC0019, DYTC0020, DYTC0021, DYTC0022, DYTC0024, DYTC0025, DYTC0026, DYTC0027, DYTC0029, DYTC0030, DYTC0031, DYTC0032, DYTC0033, DYTC0034, DYTC0035, DYTC0036, DYTC0037, DYTC0038, DYTC0039, DYTC0040, DYUC0001, DYUC0002, DYUC0004, DYUC0005, DYUC0009, DYUC0012, DYUC0014, DYUC0015, DYUC0016, DYUC0017, DYUC0018, DYUC0019, DYUC0020, DYUD0001, DYUD0002, DYUD0003, DYUD0004, DYUD0005, DYUD0006, DYUD0007, DYUD0008, DYUD0009, DYUD0011, DYUD0012, DYUD0013, DYUD0014, DYUD0015, DYUD0016, DYUD0017, DYUD0019, DYUD0020, DYUD0021, DYUD0022, DYUD0023, DYUD0026, DYUD0027, DYUD0028, DYUD0029, DYUD0030, DYUD0031, DYUD0033, DYUD0034, DYUD0035, DYUD0036, DYUD0037, DYUD0038, DYUD0039, DYUD0042, DYUD0043, DYUD0045, DYUD0046, DYUD0047, DYUD0048, DYUD0049, DYUD0050, DYUD0052, DYUD0053, DYUD0055, DYUD0057, DYUD0058, DYUD0059, DYUE0002, DYUE0007, DYUE0008, DYUE0011, and DYUE0014.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EXS
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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