Maquet Edi Catheter Recalled for Incorrect Expiry Date Labeling
Getinge is recalling Maquet Edi Catheters because the single-pack boxes are labeled with the wrong expiry date. The recall covers 17 boxes distributed in the US and several countries.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error regarding the expiry date, with no reported injuries or illnesses.
Plain-English summary
Getinge US Sales LLC is recalling 17 boxes of Maquet Servo-I Ventilator System Edi Catheters (Product Code 6685775). The recall is due to a labeling error where the single-pack boxes are marked with an incorrect expiry date. Each box contains five catheters.
The affected product is a single-use naso-gastric feeding tube with an electrode array used to detect diaphragmatic electrical activity for ventilator control and to administer nutrition, fluids, and medications. The specific lot number is 92265355.
The product was distributed worldwide, including in the US states of Florida and North Carolina, and in the countries of Austria, France, and Portugal. No illnesses or injuries have been reported in connection with this labeling error. Users should check their inventory for this specific lot and contact Getinge for instructions on how to proceed.
The recalled product
- Product
- 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…
- Manufacturer
- GETINGE US SALES LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 92265355 UDI Code: 6685775: 07325710002100
Distribution
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