FDA recall Z-0509-2021

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.

Distribution

US distribution to distributors located in CA, FL, IL, KS, NJ, NY, and TN.

Key facts

Status

Terminated

Initiation date

2020-03-23

Report date

2020-12-09

Termination date

2021-05-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0509-2021