Reported May 1, 2019 · Terminated
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage:…
Getinge US Sales LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GETINGE US SALES LLC · 45 BARBOUR POND DR · WAYNE, NJ · 07470
Is this the product you have?
- Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg
- Product Code/REF Number6685775
- Product UsageThe 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
- Lot codes and dates
- Lot Number92265355
- UDI Code6685775: 07325710002100
- Amount recalled
- 17 boxes (5 catheters per box)
Where it was sold
Why it was recalled
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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