Medical device recalls Moderate risk

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

Recall date
June 21, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2300-2021
FDA classification
Class II
Brand / firm
Delta Med SpA
Sold / distributed
US Nationwide distribution in the states of FL and MN.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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