Recall Z-2744-2018 ยท FEN Device, Cystometric, Hydraulic
ConvaTec, Inc
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 exis
| Date | Jul 3, 2018 |
| Status | Terminated |
| Reason | Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier. |
| Root 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. Ret |
| Quantity | 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, Portuga |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.