Delta Med SpA: DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573

Recall number

Z-2297-2021

Recalling firm

Delta Med SpA

Product

DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573

Status

Open, Classified

Initiated

2021-06-21

Posted

not on file

Terminated

not on file

Reason

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

Root cause

Process control

Action

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

Quantity

229,320 units

Distribution

US Nationwide distribution in the states of FL and MN.

Lot, serial or model codes

a) REF 3814773, Lot 11T00118 b) REF 3835773, Lot 11T00119 c) REF 3825773, Lot 11T00120 d) REF 3837773, Lot 11T00121 e) REF 3846773, Lot 11T00122 f) REF 3831473, Lot 11T00142 g) REF 3842473, Lot 11T00143 h) REF 3821473, Lot 11T00146 i) REF 3832473, Lot 11T00147 j) REF 3833473, Lot 11T00148 k) REF 3821573, Lot 11T00177 l) REF 3831573, Lot 11T00178 m) REF 3833573, Lot 11T00179 n) REF 3824773, Lot 11T00230 o) REF 3804773, Lot 11T00231 p) REF 3845773, Lot 11T00232 q) REF 3811473, Lot 11T05089 r) REF 3836773, Lot 11T05136 s) REF 3843473, Lot 11T05166 t) REF 3800473, Lot 11T10007 v) REF 3842573, Lot 12T00180 w) REF 3832573, Lot 11T10015 x) REF 3847773, Lot 11T10016 y) REF 3800573, Lot T1010018

510(k) numbers

["K171530"]

PMA numbers

not on file

Product code

FOZ

Firm FEI

3006846316

Firm city

Viadana

Firm state

not on file

Firm country

Italy

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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