ConvaTec recalls AbViser AutoValve IAP monitoring devices (REF ABV300/ABV301) due to potential pinhole breaches in sterile barriers. Affected units may leak fluid during use.
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
ConvaTec is recalling AbViser AutoValve IAP monitoring devices with model numbers ABV300 and ABV301 because they might have pinholes in their sterile barriers. This could allow fluid to leak during use, potentially causing infection or other complications.
The device's sterile barrier might develop pinholes during use, allowing fluid to leak. This could lead to infections or other complications if the device is not properly sealed.
Patients using the AbViser AutoValve IAP monitoring device for intra-abdominal pressure measurement are affected. Healthcare providers and patients with urinary catheters are most at risk.
Check for model numbers ABV300 or ABV301 on the device. Lot numbers for ABV300 is 150924, and for ABV301 are 160937, 161023, 161128, 170120, 170514, 170732, 170801, 170829.
Look for model numbers ABV300 or ABV301 on the device.
The device may have pinholes in its sterile barrier, which could allow fluid to leak and potentially cause infections or other complications.
Check for model numbers ABV300 or ABV301. ABV300 has lot number 150924, and ABV301 has lot numbers 160937, 161023, 161128, 170120, 170514, 170732, 170801, 170829.
The recall record does not specify a remedy, so contact ConvaTec directly for guidance.
We’ve drafted a message you can send ConvaTec to request your refund or repair — edit it as you like.
Subject: Recall Z-2744-2018 — ConvaTec ConvaTec Hello, I own a ConvaTec that is covered by recall Z-2744-2018 from ConvaTec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
