Data Foundry

Medical device recalls 2020

B — Class II medical device recall Z-0509-2021

Terminated recall by Janus Trade Group, reported 2020-12-09, distributed in CA, FL, IL, KS, NJ, NY, TN. Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.

Recall numberZ-0509-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmJanus Trade Group, Eatontown, NJ, United States
Recall initiated2020-03-23
Classified2020-11-30
Reported by FDA2020-12-09
Terminated2021-05-20
DistributedCA, FL, IL, KS, NJ, NY, TN
Lot numbers14N10G8274, 15F25G8395, 15H25G8315, 16H16G8261, 16H30G8303, 16H30G8304, 16L0G8275, 16N24G8303, 17A20G8273, 17A20G873, 17C16G8304, 17C17G8302, 17C18G8305, 17D08G8241, 17F15G8302, 17G10G8261, 17H02G8392, 17H20G8391, 17H23G8271, 17H23G8272, 17K08G8272, 17K08G8273, 17K27G8304, 17M10G8271, 17M10G8273, 17M11G8273, 17M15G8261, 18D01G8273, 18F25G8272, 18F26G8303, 18F29G8362, 18G15A272, 18G31G8316, 18G31G8392, 18H04G8261, 18H17G8272, 18HI8G8243, 18K08G8263, 18K18G8244, 18L23G8271 and 4 more
Model numbers4251644-01, 4251890-01, 4252500-01, 4252519-01, 4252535-01, 4252560-01, 4252586-01

Product

B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01

Reason for recall

Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0509-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.