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U.S. Department of Health and Human Services

Class 2 Device Recall Intraabdominal Pressure (IAP) Monitoring Device

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 Class 2 Device Recall Intraabdominal Pressure (IAP) Monitoring Devicesee related information
Date Initiated by FirmJanuary 13, 2020
Create DateMarch 02, 2020
Recall Status1 Terminated 3 on April 12, 2021
Recall NumberZ-1219-2020
Recall Event ID 84744
510(K)NumberK070201 
Product Classification Intra-abdominal pressure monitoring device - Product Code PHU
ProductThe 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.
Code Information Product Code IAP001 lot numbers NGDQ2943 and NGDS0622.
FEI Number 1018233
Recalling Firm/
Manufacturer		 C.R. Bard Inc
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information ContactTroy Kirkpatrick
858-617-2361
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionLetters were sent 01/13/2020 to the user level instructing the return of two specific product lots of IAP001, Lots NGDQ2943 and NGDS0622.
Quantity in Commerce1,300 total
DistributionDistributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = PHU
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