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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

B. Braun Medical, Inc.: The filter capacity is not achieved due to damage of the filter membrane.

Agency Publication Date: September 5, 2019
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Affected Products

Product: ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114

Lot # 0061537250 UDI: 04046964940613

Lot Numbers:
0061537250
Product: ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115

Lot # 0061620288 UDI: 04046964940637

Lot Numbers:
0061620288
Product: FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160

Lot # 0061526085 UDI: 04046964941054

Lot Numbers:
0061526085
Product: CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183

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

Lot Numbers:
0061536635
0061620271
Product: CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186

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

Lot Numbers:
0061536043
0061620273
Product: CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187

Lot # 0061620275 UDI: 04046964941412

Lot Numbers:
0061620275
Product: CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188

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

Lot Numbers:
0061537846
0061537847
0061620282
Product: CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189

Lot # 0061620283 UDI: 04046964943294

Lot Numbers:
0061620283
Product: CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191

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

Lot Numbers:
0061536641
0061643652

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83478
Status: Resolved
Manufacturer: B. Braun Medical, Inc.
Manufactured In: United States
Units Affected: 9 products (100 units; 200 units; 250 units; 540 units; 960 units; 200 units; 3820 units; 200 units; 1230 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.