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.
Recall
- Recall Number
- Z-2744-2018
- Event Number
- 80539
- Firm
- ConvaTec, Inc
- FEI Number
- 3011987967
- Product Code
- FEN
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 3, 2018
- Terminated
- January 24, 2023
- Address
- 7900 Triad Center Dr, Ste 400, Greensboro, NC, 27409-9076
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.
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
The firm, ConVaTec, sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter dated July 2, 2018, to its customers via United Parcel Service of America (UPS) Ground with tracking on July 3, 2018, with emails sent to distributors on July 9, 2018. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1. Inspect your inventory to confirm if you have any of the affected product codes. 2 Perform a count of affected product currently in inventory. Complete the enclosed response form and return it to the address on the response form. Return the attached Recall Response Form even if no affected product is in inventory. 3 If you have any affected product in inventory please contact [email protected] or call the Customer Interaction Center at the toll free number 1-800-422-8811. You will be provided further instructions regarding how to return affected product and arrange credit.
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.
3881 units