ConvaTec AbViser AutoValve IAP Monitoring Devices Recalled for Sterile Barrier Breach
ConvaTec is recalling AbViser AutoValve IAP Monitoring Devices because bubble leak testing confirmed a potential pinhole breach in the sterile barrier.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a confirmed potential breach in the sterile barrier, which poses a risk of harm (infection) even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
ConvaTec, Inc. is recalling the AbViser AutoValve IAP (intra-abdominal pressure) Monitoring Device, patient mount REF ABV300 and REF ABV301. The device is a sterile, non-invasive, disposable medical device used to measure intra-abdominal bladder pressure by attaching to a patient's existing urinary catheter or drain system.
The recall was initiated after bubble leak testing on devices without transducers confirmed the potential for a pinhole breach in the sterile barrier. This defect could compromise the sterility of the device.
A total of 3,881 units are affected. The distribution was worldwide, including the United States (nationwide) and numerous international countries. Specific lot numbers affected include 150924 for REF ABV300, and 160937, 161023, 161128, 170120, 170514, 170732, 170801, and 170829 for REF ABV301. Users should stop using these devices and contact ConvaTec for further instructions.
The recalled product
- Product
- 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 pressur
- Manufacturer
- ConvaTec, Inc
- Affected units
- 3,881
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- a) ABV 300: Lot Number 150924 b) ABV 301: Lot Numbers: 160937
- 161023
- 161128
- 170120
- 170514
- 170732
- 170801
- 170829
Distribution
Distributed nationwide across the United States.
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