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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83478

9 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 10, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
B. Braun Medical, Inc.

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

9 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 9

ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114

Z-2466-2019
Recall number
Z-2466-2019
Initiated
July 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The filter capacity is not achieved due to damage of the filter membrane.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The filter capacity is not achieved due to damage of the filter membrane.

Code information

Lot # 0061537250 UDI: 04046964940613

Distribution pattern

CA FL MO TX MN AL GA NC IL PA

device · product 2 of 9

ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115

Z-2467-2019
Recall number
Z-2467-2019
Initiated
July 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The filter capacity is not achieved due to damage of the filter membrane.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The filter capacity is not achieved due to damage of the filter membrane.

Code information

Lot # 0061620288 UDI: 04046964940637

Distribution pattern

CA FL MO TX MN AL GA NC IL PA

device · product 3 of 9

FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160

Z-2468-2019
Recall number
Z-2468-2019
Initiated
July 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The filter capacity is not achieved due to damage of the filter membrane.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The filter capacity is not achieved due to damage of the filter membrane.

Code information

Lot # 0061526085 UDI: 04046964941054

Distribution pattern

CA FL MO TX MN AL GA NC IL PA

device · product 4 of 9

CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183

Z-2469-2019
Recall number
Z-2469-2019
Initiated
July 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
540 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The filter capacity is not achieved due to damage of the filter membrane.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The filter capacity is not achieved due to damage of the filter membrane.

Code information

Lot # 0061536635 Exp: 10/31/2018 Lot # 0061620271 Exp:11/30/2019 UDI: 04046964941337

Distribution pattern

CA FL MO TX MN AL GA NC IL PA

device · product 5 of 9

CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186

Z-2470-2019
Recall number
Z-2470-2019
Initiated
July 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
960 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The filter capacity is not achieved due to damage of the filter membrane.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The filter capacity is not achieved due to damage of the filter membrane.

Code information

Lot # 0061536043 Exp: 8/31/2018 Lot # 0061620273 Exp:11/30/2019 UDI: 04046964941399

Distribution pattern

CA FL MO TX MN AL GA NC IL PA

device · product 6 of 9

CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187

Z-2471-2019
Recall number
Z-2471-2019
Initiated
July 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The filter capacity is not achieved due to damage of the filter membrane.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The filter capacity is not achieved due to damage of the filter membrane.

Code information

Lot # 0061620275 UDI: 04046964941412

Distribution pattern

CA FL MO TX MN AL GA NC IL PA

device · product 7 of 9

CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188

Z-2472-2019
Recall number
Z-2472-2019
Initiated
July 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
3820 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The filter capacity is not achieved due to damage of the filter membrane.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The filter capacity is not achieved due to damage of the filter membrane.

Code information

Lot # 0061537846 Exp: 8/31/2018 Lot # 0061537847 Exp: 10/31/2018 Lot # 0061620282 Exp: 9/30/2019 UDI: 04046964941436

Distribution pattern

CA FL MO TX MN AL GA NC IL PA

device · product 8 of 9

CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189

Z-2473-2019
Recall number
Z-2473-2019
Initiated
July 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The filter capacity is not achieved due to damage of the filter membrane.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The filter capacity is not achieved due to damage of the filter membrane.

Code information

Lot # 0061620283 UDI: 04046964943294

Distribution pattern

CA FL MO TX MN AL GA NC IL PA

device · product 9 of 9

CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191

Z-2474-2019
Recall number
Z-2474-2019
Initiated
July 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1230 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The filter capacity is not achieved due to damage of the filter membrane.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The filter capacity is not achieved due to damage of the filter membrane.

Code information

Lot # 0061536641 Exp:10/31/2018 Lot # 0061643652 Exp:11/30/2019 UDI: 04046964941474

Distribution pattern

CA FL MO TX MN AL GA NC IL PA