FDA recall Z-2300-2021

Delta Med SpA · Class II · device

Product

NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units

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-2300-2021