Facility

CSL Behring LLC

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1410248
Establishment type	Repack or Relabel Medical Device
Location	1201 N Kinzie Ave Bradley, IL, US 60915
Registration status	Active · expires 2026
Parent company	CSL Behring LLC (owner-operator 10042341)
Brand names	Surflo Winged Infusion Set with Needle Protection (Surshield)

Activity by year

Recalls (4)

Devices registered here (1)

Set, Administration, Intravascular
Product code FPA (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5440

Recalls & enforcement

Class IITerminated2020-03-02
Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring
Class IITerminated2018-05-31
Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC method. CDT results in absolute concentrations may be influenced by patients transferr…
Class IITerminated2017-06-05
Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various lots of N Protein Standard SL. N/T Protein Controls SL for Ceruloplasmin are similarly bias…
Class IITerminated2016-05-17
Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.

All facilities operated by CSL Behring LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CSL Behring LLC (FEI 1410248) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1410248-csl-behring-llc/

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