Recall record at a glance
| Official record | Z-1221-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | GETINGE US SALES LLC |
| Report date | May 1, 2019 |
| Recall initiation date | Mar 20, 2019 |
| Quantity | 17 boxes (5 catheters per box) |
| Location | WAYNE, NJ, United States |
Official product description
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 diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.
Why the product was recalled
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
Distribution information
Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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