CLASS II ONGOING Device recall · Reported 25 Aug 2021 · FDA Enforcement Report

Deltaven Fastflash, Safety I.V recalled by Delta Med SpA

Delta Med SpA is recalling Deltaven Fastflash, Safety I.V, distributed nationwide in the US. The recall was initiated on 21 Jun 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 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

Quantity recalled229,320 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2297-2021
FDA event ID: 88234
Recalling firm: Delta Med SpA, Viadana, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 21 Jun 2021
FDA classified: 16 Aug 2021
Reported: 25 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

21 Jun 2021	Recall initiated by company
16 Aug 2021	Classified by FDA	+56 days
25 Aug 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of FL and MN.

Nationwide Florida Minnesota

Questions about this recall

Is Deltaven Fastflash, Safety I.V recalled?

Yes. Delta Med SpA recalled Deltaven Fastflash, Safety I.V on 21 Jun 2021. The recall is Class II and its status is Ongoing. Recall number Z-2297-2021.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the states of FL and MN.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Delta Med SpA

All 11

Reported	Class	Recall	Company	Reason	Where
25 Aug 2021Device	CLASS II	Deltaven Y, Safety I.V recalled by Delta Med SpA	Delta Med SpA	Sterility	Nationwide
25 Aug 2021Device	CLASS II	Neo Delta Selfsafe Pur 1, I.v recalled by Delta Med SpA	Delta Med SpA	Sterility	Nationwide
25 Aug 2021Device	CLASS II	Deltaven Safety I.V recalled by Delta Med SpA	Delta Med SpA	Sterility	Nationwide
25 Aug 2021Device	CLASS II	Wolf-pak Self Safe Safety IV Catheter: a) recalled by Delta Med SpA	Delta Med SpA	Sterility	Nationwide
25 Aug 2021Device	CLASS II	Neo Delta Selfsafe Pur T, I.v recalled by Delta Med SpA	Delta Med SpA	Sterility	Nationwide

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