Recall Z-0414-2022 ยท LJE Catheter, Nephrostomy
Cook Inc.
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
| Date | Oct 13, 2021 |
| Status | Open, Classified |
| Reason | Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used. |
| Root cause | Process change control |
| Action | On October 13, 2021, the firm distributed Urgent Medical Device Recall letters to customers. Customers were informed that the needles may contain black debris on the exterior of the inner stylet and/or the interior of the outer cannula. Potential adverse events that may occur if an affected product is used include local/self-limited inflammatory reactions. To date, Cook has received no complaints related to this issue. However, please be advised that the presence of black debris may go undetected by the user. Actions to be Taken by the Customer 1. Examine inventory immediately to determine i |
| Quantity | 112 US, 240 OUS |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, CA, IN, LA, MS, MT, NC, NY, OR, PA, WA and the countries of France, Italy, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.