Home / Recalls / ConvaTec, Inc / Z-2744-2018

Z-2744-2018 Class II Terminated

Recalled by ConvaTec, Inc — Greensboro, NC

FDA device recall Z-2744-2018 was initiated by ConvaTec, Inc on Jul 3, 2018 and is designated Class II. Reason for recall: Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier. The recall status is terminated (terminated Jan 24, 2023). Affected quantity: 3881 units.

Recall Details

Product Type
Devices
Report Date
Aug 22, 2018
Initiation Date
Jul 3, 2018
Termination Date
Jan 24, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3881 units

Product Description

AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.

Reason for Recall

Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.

Distribution Pattern

worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Canada, Bahrain, Bangladesh, Belgium, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, India, Israel, Italy, Kenya, Kuwait, Malta, Mauritius, Netherlands,Norway, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam.

Code Information

a) ABV 300: Lot Number 150924 b) ABV 301: Lot Numbers: 160937, 161023, 161128, 170120, 170514, 170732, 170801, 170829

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2744-2018
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources