Z-0509-2021Class II

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

Name: Z-0509-2021 B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01...
Creator: Janus Trade Group
Published: 2020-03-23
License: https://open.fda.gov/license/

Janus Trade Group / initiated 2020-03-23 / Terminated

FDA source

Janus Trade Group began a recall of 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 on 2020-03-23. FDA classified it as Class II and gives the reason as "Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0509-2021
Classification: Class II
Status: Terminated
Initiated: 2020-03-23
Posted: 2020-11-30
Terminated: 2021-05-20
Recalling firm: Janus Trade Group
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
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.
FDA root cause: No Marketing Application
Action: Between March 13-25, 2020, Janus Trade Group made phone contact with customers requesting to check if customers had product on hand. If customers had product on hand, they were asked to send it back to JTG for a full refund.
Quantity in commerce: 1365 cases (200 units/case)
Distribution: US distribution to distributors located in CA, FL, IL, KS, NJ, NY, and TN.
Product codes and lots: Lots 18L23G8271 17A20G8273 18M02G8315 16H16G8261 18K18G8244 17D08G8241 16H16G8261 15H25G8315 18G15A272 18G31G8316 18G31G8392 17H20G8391 18M02G8315 18M02G8315 18F29G8362 18D01G8273 17K08G8272 17K08G8273 17G10G8261 19A12G8272 19A12G8272 18H17G8272 18H17G8272 18F26G8303 18H04G8261 15F25G8395 17K27G8304 17C16G8304 17H02G8392 17F15G8302 17M10G8271 17M10G8273 17M15G8261 17C17G8302 17C18G8305 18M20G8271 18L29G8271 18K08G8263 18HI8G8243 18F25G8272 18F25G8272 17M11G8273 17H23G8272 17H23G8271 17H23G8271 18L23G8271 18L23G8271 17A20G8273 17A20G873 17A20G8273 17D08G8241 17D08G8241 17D08G8241 16N24G8303 16H30G8303 16H30G8304 16L0G8275 14N10G8274 16H16G8261

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0509-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0509-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-11-30

Product code FOZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)