Recall Z-0285-2020 ยท NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Becton Dickinson & Company
13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media, and central venous pressure monitoring.
| Date | Sep 16, 2019 |
| Status | Terminated |
| Reason | A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter. |
| Root cause | Under Investigation by firm |
| Action | On September 16, 2019, the firm distributed Urgent Medical Device Recall notices to affected customers. Customers were asked to take the following actions: 1. Immediately examine your inventory for the product code and lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Please share this recall notification with all users of the product to ensure they are also aware of the recall. 3. Complete the Customer Response Form (even if you do not have affected lots in your inventory) and return to the BD contact noted on the form |
| Quantity | 75 units |
| Distribution | Distributed to healthcare facilities in AR, FL, IL, NJ, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133456 | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER C.R. Bard, Inc., Sep 24, 2014 |