RegWardenFDA facility compliance records
Recall

Class II — B. Braun Medical, Inc.

Recalling firmB. BRAUN MEDICAL INC.
Registered facilityView this company's 5 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThe catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
ProductCNB200TKU NON-STIM CATH FULL KIT, Material Number 332127 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
Quantity880
DistributionWorldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.
Initiated2018-07-20
Classified2018-10-01
Terminated2020-05-13
Recall numberZ-3345-2018
InitiationVoluntary: Firm initiated

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

Cite this record

RegWarden. “Class II recall — B. Braun Medical, Inc. (Z-3345-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80811/

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