FDA Device

DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272

Hazard

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

What You Should Do

Remedy

The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.

Products

DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Brand
Delta Med SpA Via Guido Rossa 20 Viadana Italy
UPC
a) REF 3836272, Lot 11T80188 b) REF 3814272, Lot 11T80272 c) REF 3845272, Lot 12T80147 d) REF 3856272, Lot 12T80347

Units Affected

30,900 units