Z-2297-2021Class II

DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF...

Name: Z-2297-2021 DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF...
Creator: Delta Med SpA
Published: 2021-06-21
License: https://open.fda.gov/license/

Delta Med SpA / initiated 2021-06-21 / Open, Classified / root cause: manufacturing process

FDA source

Delta Med SpA began a recall of 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... on 2021-06-21. FDA classified it as Class II and gives the reason as "Problems related to the sterilization of the medical devices; possible missing sterility of the medical device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2297-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-21
Posted: 2021-08-16
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
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Root cause tag: manufacturing process
FDA 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 in commerce: 229,320 units
Distribution: US Nationwide distribution in the states of FL and MN.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2297-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2295-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2296-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2297-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2298-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2299-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2300-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2301-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2302-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2303-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2304-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16
Z-2305-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16

Product code FOZ

K171530Class IIDeltaven XiV Max, Deltaven XiV Max FFDelta Med Spa / cleared 2017-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)