FDA recall Z-2302-2021

Product

NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122

Reason for recall

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

Distribution

US Nationwide distribution in the states of FL and MN.

Key facts

Status

Ongoing

Initiation date

2021-06-21

Report date

2021-08-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Viadana, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2302-2021