FDA-Device2021-08-25Class II

NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

Delta Med SpA
Hazard

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

Sold states
US Nationwide distribution in the states of FL and MN.
Affected count
20,000 units
Manufactured in
Via Guido Rossa 20, N/A, Viadana, N/A, Italy
Products
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2301-2021

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