Class 2 Device Recall AbViser AutoValve IAP Monitoring Device

• Date Initiated by Firm: July 03, 2018
• Create Date: August 10, 2018
• Recall Status: Terminated on January 24, 2023
• Recall Number: Z-2744-2018
• Recall Event ID: 80539
• Product Classification: Device, cystometric, hydraulic - Product Code FEN
• 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 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.
• Code Information: a) ABV 300: Lot Number 150924 b) ABV 301: Lot Numbers: 160937, 161023, 161128, 170120, 170514, 170732, 170801, 170829
• FEI Number: 3011987967
• Recalling Firm/ Manufacturer: ConvaTec, Inc; 7900 Triad Center Dr Ste 400; Greensboro NC 27409-9076
• For Additional Information Contact: media relations; 336-547-3730
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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 ic@convatec.com 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.
• Quantity in Commerce: 3881 units
• Distribution: 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.
• Total Product Life Cycle: TPLC 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.