Recall Z-1221-2019 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
GETINGE US SALES LLC
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting
| Date | Mar 20, 2019 |
| Status | Terminated |
| Reason | Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes |
| Root cause | Under Investigation by firm |
| Action | Maquet issued letters to customers on March 20, 2019 via FedEx Standard Overnight states issue, health risk and action to take: remove product and contact Getinge Customer Service at 1-888-627-8383 (press option 2, then option 3) to request a return authorization (RMA) and shipping instructions to return any affected product. Questions please contact your Getinge representative or call the Getinge Customer Support at 1-888-627-8383 (press option 2, then option 3), Monday through Friday from 6:00 a.m. and 5:00 p.m. PST. |
| Quantity | 17 boxes (5 catheters per box) |
| Distribution | Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153688 | Edi Catheter ENFit Maquet Critical Care AB, Mar 2, 2017 |