Exact FDA event identifier

Event 82533

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: March 20, 2019
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: GETINGE US SALES LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1221-2019

Recall number: Z-1221-2019
Initiated: March 20, 2019
Classification: Class III
Status: Terminated
Recalling firm: GETINGE US SALES LLC
Quantity: 17 boxes (5 catheters per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes

Code information

Lot Number: 92265355 UDI Code: 6685775: 07325710002100

Distribution pattern

Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.