Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 19, 2020
The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured.
Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be c…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
C.r. Bard Inc recalled The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for … - a moderate-severity action.
The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for … was recalled by C.r. Bard Inc in February 19, 2020. Reason: Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead…. Check the official notice for the remedy. Verify recall #Z-1219-2020 with the FDA Devices before acting.
The recall
C.r. Bard Inc issued this moderate-severity FDA Devices recall-Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead….
- Moderate
- severity level
- Class II
- classification
- February 19, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1219-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1219-2020) was formally reported on February 19, 2020, with the manufacturer initiating the action on January 13, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. C.r. Bard Inc is listed as the recalling firm, operating out of Covington, GA. Federal records list the affected scope as 1,300 total.
The documented reason for this recall is: Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed with other means, such as a new… Distribution data in the federal record shows the product reached: Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,300 total
Related Recalls
6
3 from same agency
Product description
The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured.
Reason for recall
Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed with other means, such as a new IAP system of the same kind or by choosing other diagnostic means such as but not limited to alternative systems, such as open IAP measurement options or exchanging the tubing system, which does not require invasive maneuvers.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1219-2020 |
| Date reported | February 19, 2020 |
| Date initiated | January 13, 2020 |
| Recalling firm | C.r. Bard Inc |
| Firm location | Covington, GA |
| Affected scope | 1,300 total |
| Distribution | Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1219-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured.. Recalled by C.r. Bard Inc. Units affected: 1,300 total.
Why was this product recalled? ▼
Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed with other means, such as a new IAP system of the same kind or by choosing other diagnostic means such as but not limited to alternative systems, such as open IAP measurement options or exchanging the tubing system, which does not require invasive maneuvers.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1219-2020.
Where was the recalled product distributed? ▼
Distribution: Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1219-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 19, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.