Exact FDA event identifier

Event 88234

11 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: June 21, 2021
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Delta Med SpA

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

11 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 11

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

Z-2295-2021

Recall number: Z-2295-2021
Initiated: June 21, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Delta Med SpA
Quantity: 30,900 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) REF 3836272, Lot 11T80188 b) REF 3814272, Lot 11T80272 c) REF 3845272, Lot 12T80147 d) REF 3856272, Lot 12T80347

Distribution pattern

US Nationwide distribution in the states of FL and MN.

device · product 2 of 11

DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572

Z-2296-2021

Recall number: Z-2296-2021
Initiated: June 21, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Delta Med SpA
Quantity: 203,680 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) REF 3832572: Lot 11T80189 b) REF 3842572, Lot 11T80198 c) REF 3821572, Lot 11T80149 d) REF 3833572, Lot 11T80292 e) REF 3831572, Lot 12T80230 f) REF 3810572, Lot 12T80302 g) REF 3852572, Lot 12T80349

Distribution pattern

US Nationwide distribution in the states of FL and MN.

device · product 3 of 11

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

Z-2297-2021

Recall number: Z-2297-2021
Initiated: June 21, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Delta Med SpA
Quantity: 229,320 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

US Nationwide distribution in the states of FL and MN.

device · product 4 of 11

DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072

Z-2298-2021

Recall number: Z-2298-2021
Initiated: June 21, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Delta Med SpA
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) REF 3832072, Lot 11T80190 b) REF 3810072, Lot 11T80303 c) REF 3842072, Lot 12T80342 d) REF 3852072, Lot 12T80348

Distribution pattern

US Nationwide distribution in the states of FL and MN.

device · product 5 of 11

NEO DELTA Self Safe, I.V. Catheter REF 3738222

Z-2299-2021

Recall number: Z-2299-2021
Initiated: June 21, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Delta Med SpA
Quantity: 10,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

REF 3738222, Lot 00A1160625

Distribution pattern

US Nationwide distribution in the states of FL and MN.

device · product 6 of 11

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

Z-2300-2021

Recall number: Z-2300-2021
Initiated: June 21, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Delta Med SpA
Quantity: 5000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

REF 3708122, Lot 00A1160627

Distribution pattern

US Nationwide distribution in the states of FL and MN.

device · product 7 of 11

NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

Z-2301-2021

Recall number: Z-2301-2021
Initiated: June 21, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Delta Med SpA
Quantity: 20,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) REF 3779422, Lot 00A1160635 b) REF 3769522, Lot 00A1160656 c) REF 3708522, Lot 00A1160638

Distribution pattern

US Nationwide distribution in the states of FL and MN.

device · product 8 of 11

NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122

Z-2302-2021

Recall number: Z-2302-2021
Initiated: June 21, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Delta Med SpA
Quantity: 1400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot 00A1160806

Distribution pattern

US Nationwide distribution in the states of FL and MN.

device · product 9 of 11

NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822

Z-2303-2021

Recall number: Z-2303-2021
Initiated: June 21, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Delta Med SpA
Quantity: 14,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) REF 3738522, Lot 00A2160813 b) REF 3738822, Lot 00A1160822

Distribution pattern

US Nationwide distribution in the states of FL and MN.

device · product 10 of 11

NEO DELTA SELFSAFE PUR T, I.V. Catheter:

Z-2304-2021

Recall number: Z-2304-2021
Initiated: June 21, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Delta Med SpA
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

REF 3738522, Lot 00A2160813 REF 3738822, Lot 00A1160822

Distribution pattern

US Nationwide distribution in the states of FL and MN.

device · product 11 of 11

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

Z-2305-2021

Recall number: Z-2305-2021
Initiated: June 21, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Delta Med SpA
Quantity: 40,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084

Distribution pattern

US Nationwide distribution in the states of FL and MN.