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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94274

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

Open FDA event record

Event summary

Timeline bucket
March 19, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Perfusion Systems

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

13 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 13

Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 87120; e) DLP¿ Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 80222; f) DLP¿ Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 87122; g) DLP¿ Curved Tip Arterial Cannula 20 Fr., Model Number 87220; h) DLP¿ Curved Tip Arterial Cannula 22 Fr., Model Number 87222; i) DLP" One-Piece Arterial Cannulae, Pediatric 6 Fr, Model Number 77006; j) DLP" One-Piece Pediatric Arterial Cannula 6 Fr, Model Number 77206; k) DLP" One-Piece Pediatric Arterial Cannula 8 Fr, Model Number 77008; l) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77010; m) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77110; n) DLP" One-Piece Pediatric Arterial Cannula 12 Fr, Model Number 77112; o) EOPA" Elongated One Piece Arterial Cannula 20 Fr., Model Number 77420; p) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77422; q) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77522; r) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77622; s) EOPA" Elongated One Piece Arterial Cannula 24 Fr., Model Number 77524; t) Select Series" Angled Tip Arterial Cannula 24Fr., Model Number 72424; u) Select Series" Straight Tip Arterial Cannula 20 Fr., Model Number 72120; v) Select Series" Straight Tip Arterial Cannula 24 Fr., Model Number 72224

Z-1793-2024
Recall number
Z-1793-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
13033 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

a) Model Number 80020, GTIN 20643169485703, Lot Numbers: 2023040597, 2023041061, 202305C247; b) Model Number 80220, GTIN 20643169485734, Lot Numbers: 2023031390, 2023040098, 202305C249, 202310C155; c) Model Number 82020, GTIN 20643169485536, Lot Numbers: 2023041063, 2023041396, 202305C253; d) Model Number 87120, GTIN 00673978187105, Lot Numbers: 2023040600; GTIN 20613994879114, Lot Numbers: 2023040600, 2023041066, 202306C018; e) Model Number 80222, GTIN 20643169485741, Lot Numbers: 2023041062, 202308C058; f) Model Number 87122, GTIN 00613994879103, Lot Numbers: 2023040601; GTIN 20613994879107, Lot Numbers: 2023040601, 2023041067, 202306C017; g) Model Number 87220, GTIN 00643169485563, Lot Numbers: 2023031282, 2023040602, 2023041068; GTIN 20643169485567, Lot Numbers: 2023031282, 2023031283, 2023031391, 2023040602, 2023041068, 202306C006, 202306C247; h) Model Number 87222, GTIN 00643169485570, Lot Numbers: 2023041408; GTIN 20643169485574, Lot Numbers: 2023041069, 2023041408, 202306C007; i) Model Number 77006, GTIN 20763000091013, Lot Numbers: 2023040943, 202306C056; j) Model Number 77206, GTIN 20763000091020, Lot Numbers: 2023041347, 202308C108; k) Model Number 77008, GTIN 20763000091105, Lot Numbers: 2023040944, 2023040946, 02306C020, 202308C084; l) Model Number 77010, GTIN 20763000091112, Lot Numbers: 2023041337, 202306C023; m) Model Number 77110, GTIN 00673978185989, Lot Numbers: 2023041342; GTIN 20763000091174, Lot Numbers: 2023041342, 202308C104; n) Model Number 77112, GTIN 00673978186009, Lot Numbers: 2023041343; GTIN 20763000091181, Lot Numbers: 2023041343, 202308C106; o) Model Number 77420, GTIN 20763000135625, Lot Numbers: 2023040668, 2023040671, 202306C032, 202307C005; p) Model Number 77422, GTIN 20763000135632, Lot Numbers: 2023040966, 2023041355, 202306C043, 202306C046; q) Model Number 77522, GTIN 20763000135557, Lot Numbers: 2023041361, 2023041364, 202306C051; r) Model Number 77622, GTIN 00763000135676, Lot Numbers: 2023040971; GTIN 20763000135670, Lot Numbers: 2023040971, 2023040974, 2023040978, 2023040980, 202306C061, 202307C029, 202307C030; s) Model Number 77524, GTIN 20763000135564, Lot Numbers: 2023041365, 202306C052; t) Model Number 72424, GTIN 20643169485468, Lot Numbers: 2023040940; u) Model Number 72120, GTIN 00643169485938, Lot Numbers: 2023041326; GTIN 20643169485932, lot Numbers: 2023041326, 202305C184; v) Model Number 72224, GTIN 20613994879701, Lot Numbers: 2023041332

Distribution pattern

Worldwide distribution.

device · product 2 of 13

Medtronic Clearview Blower/Mister, Model Number 22120

Z-1794-2024
Recall number
Z-1794-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
500 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

GTIN 20643169888672, Lot Numbers: 2023040203, 2023040473

Distribution pattern

Worldwide distribution.

device · product 3 of 13

Medtronic DLP Coronary Ostial Cannulae, Model Number 30050

Z-1795-2024
Recall number
Z-1795-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

GTIN 00613994576019, Lot Numbers: 2023070529; GTIN 20613994576013, Lot Numbers: 2023070529

Distribution pattern

Worldwide distribution.

device · product 4 of 13

Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001

Z-1796-2024
Recall number
Z-1796-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
7935 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

GTIN 00613994575319, Lot Numbers: 2023041320, 2023041323; GTIN 00673978180465, Lot Numbers: 2023041316, 2023041323; GTIN 20613994575313, Lot Numbers: 2023041316, 2023041318, 2023041320, 2023041323, 202305C146, 202305C154

Distribution pattern

Worldwide distribution.

device · product 5 of 13

Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP¿ Pericardial Sump 38.1 cm (15 in), Model Number 12010,

Z-1797-2024
Recall number
Z-1797-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
13954 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

a) Model Number 12012, GTIN 20613994619246, Lot Numbers: 2023050080, 202306C144; b) Model Number 12008, GTIN 00643169880665, Lot Numbers: 2023040819; b) Model Number 12008, GTIN 00673978176307, Lot Numbers: 2023040819, 2023040820; b) Model Number 12008, GTIN 20643169880669, Lot Numbers: 2023040819, 2023040820, 202307C103; c) Model Number 12001, GTIN 00643169878686, Lot Numbers: 2023040810; c) Model Number 12001, GTIN 20643169878680, Lot Numbers: 2023040810, 2023040811, 202306C141; d) Model Number 12113, GTIN 20643169881338, Lot Numbers: 2023090675; e) Model Number 12016, GTIN 20613994540434, Lot Numbers: 2023050083, 202305C093; f) Model Number 12002, GTIN 20613994540465, Lot Numbers: 2023041178, 202305C079; g) Model Number 12220, GTIN 00613994540355, Lot Numbers: 2023041202, 2023050095; g) Model Number 12220, GTIN 20613994540359, Lot Numbers: 2023041202, 2023050095, 202305C096, 202306C159; h) Model Number 12010, GTIN 00673978176321, Lot Numbers: 2023041180, 2023041182, 2023041183, 2023041188, 2023041189, 2023050075; h) Model Number 12010, GTIN 20613994619215, Lot Numbers: 2023041180, 2023041181, 2023041182, 2023041183, 2023041184, 2023041188, 2023041189, 2023050075, 202305C086, 202305C087

Distribution pattern

Worldwide distribution.

device · product 6 of 13

Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model Number 79009

Z-1798-2024
Recall number
Z-1798-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
1760 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

a) Model Number 79004, GTIN 20613994576389, Lot Numbers: 2023081324; b) Model Number 79009, GTIN 20613994576457, Lot Numbers: 2023041000, 2023041384, 202305C235

Distribution pattern

Worldwide distribution.

device · product 7 of 13

Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 30003

Z-1799-2024
Recall number
Z-1799-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
5719 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

a) Model Number 30004, GTIN 00613994646156, Lot Numbers: 2023041305; a) Model Number 30004, GTIN 00673978179841, Lot Numbers: 2023041300; a) Model Number 30004, GTIN 20613994646150, Lot Numbers: 2023041300, 2023041305, 202306C194; b) Model Number 30003, GTIN 20613994646174, Lot Numbers: 2023041298, 202306C221

Distribution pattern

Worldwide distribution.

device · product 8 of 13

Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L

Z-1800-2024
Recall number
Z-1800-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
2622 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

a) Model Number 24009, GTIN 00673978178646, Lot Numbers: 2023040211, 2023040854, 2023041224; a) Model Number 24009, GTIN 20613994495420, Lot Numbers: 2023031043, 2023031563, 2023040211, 2023040480, 2023040854, 2023040855, 2023041224, 202305C108, 202305C109, 202306C196; b) Model Number 11316, GTIN 20613994676140, Lot Numbers: 2023040437; c) Model Number 11014L, GTIN 20613994495499, Lot Numbers: 2023040807, 2023040808, 202305C076, 202306C138

Distribution pattern

Worldwide distribution.

device · product 9 of 13

Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003, d) DLP¿ 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000, e) DLP¿ 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G, f) DLP¿ Perfusion/Venting Adapter, Model Number 13002, g) DLP¿ Y Adapter Coronary Perfusion, Model Number 10710

Z-1801-2024
Recall number
Z-1801-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
6290 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

a) Model Number 25009, GTIN 20613994918608, Lot Numbers: 2023040212, 202305C110; b) Model Number 25010, GTIN 20613994918585, Lot Numbers: 2023041227, 202305C111; c) Model Number 14003, GTIN 00613994619662, Lot Numbers: 2023040464; c) Model Number 14003, GTIN 20613994619666, Lot Numbers: 2023040463, 2023040464, 202305C102; d) Model Number 14000, GTIN 00613994619716, Lot Numbers: 2023041205, 2023041206; d) Model Number 14000, GTIN 20613994619710, Lot Numbers: 2023041205, 2023041206, 202305C098, 202305C099; e) Model Number 11001G, GTIN 00613994918550, Lot Numbers: 2023031005; e) Model Number 11001G, GTIN 20613994918554, Lot Numbers: 2023030371, 2023030659, 2023031004, 2023031005, 2023031530, 2023040160, 2023040431, 2023040432, 2023040804, 2023040805, 2023041171, 202306C131, 202306C136, 202308C218; f) Model Number 13002, GTIN 20613994756057, Lot Numbers: 2023040459, 202305C097; g) Model Number 10710, GTIN 20613994685937, Lot Numbers: 20613994685937

Distribution pattern

Worldwide distribution.

device · product 10 of 13

Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000

Z-1802-2024
Recall number
Z-1802-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
1624 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

a) Model Number 61000, GTIN 00643169880955, Lot Numbers: 2023030432, 2023030433; a) Model Number 61000, GTIN 20643169880959, Lot Numbers: 2023030431, 2023030432, 2023030433, 2023030734, 202305C226, 202307C176, 202307C177; b) Model Number 62000, GTIN 20613994846642, Lot Numbers: 2023030223, 2023030736, 2023031580, 202305C225

Distribution pattern

Worldwide distribution.

device · product 11 of 13

Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200

Z-1803-2024
Recall number
Z-1803-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
1410 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

a) Model Numbers: 31100, GTIN 20885074257116, Lot Numbers: 2023081208; b) Model Numbers: 31125, GTIN 20885074257406, lot Numbers: 2023041455, 202306C205; c) Model Numbers: 31200, GTIN 00885074257433, Lot Numbers: 2023040542; c) Model Numbers: 31200, GTIN 20885074257437, Lot Numbers: 2023040542, 2023041002, 202305C173

Distribution pattern

Worldwide distribution.

device · product 12 of 13

Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10052, c) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10053, d) DLP¿ Suction Tube 10 Fr. Shaft with 20 Fr. Pool Tip, Model Number: 10060, e) DLP¿ Suction Tube 16 Fr. Shaft with 20 Fr. Fluted Tip, Model Number: 10061

Z-1804-2024
Recall number
Z-1804-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
13198 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

a) Model Number: 10050, GTIN 20613994698272, Lot Numbers: 2023041269; b) Model Number: 10052, GTIN 20613994698319, Lot Numbers: 2023041270, 202305C072; c) Model Number: 10053, GTIN 20613994698333, Lot Numbers: 2023041271, 202305C071; d) Model Number: 10060, GTIN 20613994570448, Lot Numbers: 2023041164; e) Model Number: 10061, GTIN 00613994570468, Lot Numbers: 2023041284; e) Model Number: 10061, GTIN 00763000860820, Lot Numbers: 2023040913, 2023041284; e) Model Number: 10061, GTIN 20613994570462, Lot Numbers: 2023040913, 2023040914, 2023041273, 2023041274, 2023041275, 2023041277, 2023041278, 2023041279, 2023041281, 2023041282, 2023041284, 2023041285, 202305C056, 202305C057

Distribution pattern

Worldwide distribution.

device · product 13 of 13

Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP¿ 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP¿ 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130, e) DLP¿ 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134, f) DLP¿ 12 Fr. Single Stage Venous Cannula, Model Number 67312, g) DLP¿ 16 Fr. Single Stage Venous Cannula, Model Number 67316, h) DLP¿ 16 Fr. Single Stage Venous Cannula, Model Number 67516, i) DLP¿ 18 Fr. Single Stage Venous Cannula, Model Number 66118, j) DLP¿ 18 Fr. Single Stage Venous Cannula, Model Number 67318, k) DLP¿ 20 Fr. Single Stage Venous Cannula, Model Number 67320, l) DLP¿ 20 Fr. Single Stage Venous Cannula, Model Number 69320, m) DLP¿ 20 Fr. Single Stage Venous Cannula, Model Number 67520, n) DLP¿ 22 Fr. Single Stage Venous Cannula, Model Number 66122, o) DLP¿ 22 Fr. Single Stage Venous Cannula, Model Number 67522, p) DLP¿ 24 Fr. Single Stage Venous Cannula, Model Number 67524, q) DLP¿ 26 Fr. Single Stage Venous Cannula, Model Number 67526, r) DLP¿ 28 Fr. Single Stage Venous Cannula, Model Number 66128, s) DLP¿ 28 Fr. Single Stage Venous Cannula, Model Number 39628, t) DLP¿ 28 Fr. Single Stage Venous Cannula, Model Number 67528, u) DLP¿ 30 Fr. Single Stage Venous Cannula, Model Number 66130, v) DLP¿ 31 Fr. Single Stage Venous Cannula, Model Number 69331, w) DLP¿ 32 Fr. Single Stage Venous Cannula, Model Number 66132, x) DLP¿ 34 Fr. Single Stage Venous Cannula, Model Number 67534, y) DLP¿ 36 Fr. Single Stage Venous Cannula, Model Number 66236, z) MC2¿ 28/36 Fr. Two Stage Venous Cannula, Model Number 91228, aa) MC2¿ 29/37 Fr. Two Stage Venous Cannula, Model Number 91229C, bb) MC2¿ 32/40 Fr. Two Stage Venous Cannula, Model Number 91263, cc) MC2¿ 32/40 Fr. Two Stage Venous Cannula, Model Number 91240C, dd) MC2¿ 32/40 Fr. Two Stage Venous Cannula, Model Number 91263C, ee) MC2¿ 34/46 Fr. Two Stage Venous Cannula, Model Number 91246, ff) MC2¿ 34/46 Fr. Two Stage Venous Cannula, Model Number 91246C, gg) MC2¿ 36/46 Fr. Two Stage Venous Cannula, Model Number 91236C, hh) MC2¿ 36/51 Fr. Two Stage Venous Cannula, Model Number 91251, ii) MC2¿ 36/51 Fr. Two Stage Venous Cannula, Model Number 91251C, jj) VC2" 34/38 Fr. Venous Cannula, Model Number 93438, kk) VC2" 34/48 Fr. Venous Cannula, Model Number 93448C

Z-1805-2024
Recall number
Z-1805-2024
Initiated
March 19, 2024
Classification
Class II
Status
Ongoing
Quantity
17221 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed sterile packing.

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

Potential for unsealed sterile packing.

Code information

a) Model Number 68120, GTIN 20613994879435, Lot Numbers: 2023041436; b) Model Number 68124, GTIN 00613994879417, Lot Numbers: 2023041441, 2023041448; b) Model Number 68124, GTIN 00681490466349, Lot Numbers: 2023041441, 2023041448; b) Model Number 68124, GTIN 20613994879411, Lot Numbers: 2023041441, 2023041448, 202306C008; c) Model Number 68128, GTIN 00613994879394, Lot Numbers: 2023041040; c) Model Number 68128, GTIN 00681490466363, Lot Numbers: 2023041388; c) Model Number 68128, GTIN 20613994879398, Lot Numbers: 2023041040, 2023041388, 202306C010, 202306C011; d) Model Number 68130, GTIN 20613994879381, Lot Numbers: 2023041390, 202308C131; e) Model Number 68134, GTIN 20613994879367, Lot Numbers: 2023041431; f) Model Number 67312, GTIN 00613994879325, Lot Numbers: 2023041423; f) Model Number 67312, GTIN 00673978184180, Lot Numbers: 2023040074; f) Model Number 67312, GTIN 20613994879329, Lot Numbers: 2023040073, 2023040074, 2023041423; g) Model Number 67316, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416; g) Model Number 67316, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264; h) Model Number 67516, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416; h) Model Number 67516, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264; i) Model Number 66118, GTIN 00613994878526, Lot Numbers: 2023041014; i) Model Number 66118, GTIN 20613994878520, Lot Numbers: 2023041014, 2023041015; j) Model Number 67318, GTIN 00613994879295, Lot Numbers: 2023040077; j) Model Number 67318, GTIN 00673978184241, Lot Numbers: 2023040077, 2023041391; j) Model Number 67318, GTIN 20613994879299, Lot Numbers: 2023040077, 2023041391, 202305C256; k) Model Number 67320, GTIN 00613994879288, Lot Numbers: 2023031377; k) Model Number 67320, GTIN 00673978184258, Lot Numbers: 2023031377; k) Model Number 67320, GTIN 20613994879282, Lot Numbers: 2023031377, 202307C051; l) Model Number 69320, GTIN 00613994879233, Lot Numbers: 2023041422; l) Model Number 69320, GTIN 00673978184609, Lot Numbers: 2023041422; l) Model Number 69320, GTIN 20613994879237, Lots Numbers: 2023041422, 2023041438, 202306C014, 202306C015; m) Model Number 67520, GTIN 00613994878359, Lot Numbers: 2023040082; m) Model Number 67520, GTIN 20613994878353, Lot Numbers: 2023040082; n) Model Number 66122, GTIN 20613994878544, Lot Numbers: 2023041016; o) Model Number 67522, GTIN 00613994878366, Lot Numbers: 2023040083, 2023040565; o) Model Number 67522, GTIN 00673978184326, Lot Numbers: 2023040083, 2023040565; o) Model Number 67522, GTIN 20613994878360, Lot Numbers: 2023040083, 2023040565, 202307C050; p) Model Number 67524, GTIN 00673978184333, Lot Numbers: 2023040084; p) Model Number 67524, GTIN 20613994878377, Lot Numbers: 2023040084, 2023040566, 202305C257; q) Model Number 67526, GTIN 00673978165585, Lot Numbers: 2023040569; q) Model Number 67526, GTIN 20613994878384, Lot Numbers: 2023040569, 202308C082; r) Model Number 66128, GTIN 00613994878571, Lot Numbers: 2023041020; r) Model Number 66128, GTIN 20613994878575, Lot Numbers: 2023041020, 202305C177; s) Model Number 39628, GTIN t) Model Number 67528, GTIN 20613994878391, Lot Numbers: 2023041036; u) Model Number 66130, GTIN 00613994878588, Lot Numbers: 2023040555, 202305C217; u) Model Number 66130, GTIN 20613994878582, Lot Numbers: 2023040555, 2023041414, 202305C217, 202305C218; v) Model Number 69331, GTIN 20613994879183, Lot Numbers: 2023041444, 202307C012; w) Model Number 66132, GTIN 00613994878601, Lot Numbers: 2023041428; w) Model Number 66132, GTIN 20613994878605, Lot Numbers: 2023041412, 2023041428, 202305C227; x) Model Number 67534, GTIN 20613994878421, Lot Numbers: 2023031249, 202308C079; y) Model Number 66236, GTIN 20613994878643, Lot Numbers: 2023041398, 202305C222; z) Model Number 91228, GTIN 20643169463015, Lot Numbers: 2023041070; aa) Model Number 91229C, GTIN 20643169463060, Lot Numbers: 2023041071; bb) Model Number 91263, GTIN 00673978187761, Lot Numbers: 2023041095; bb) Model Number 91263, GTIN 20613994887454, Lot Numbers: 2023041095, 202306C105; cc) Model Number 91240C, GTIN 00613994887306, Lot Numbers: 2023041082, 2023041083, 2023041084; cc) Model Number 91240C, GTIN 20613994887300, Lot Numbers: 2023041079, 2023041081, 2023041082, 2023041083, 2023041084, 2023041087, 2023041088, 202306C074, 202306C075, 202306C076, 202306C077; dd) Model Number 91263C, GTIN 20613994887447, Lot Numbers: 2023040116, 2023041097, 202306C103; ee) Model Number 91246, GTIN 00613994887535, Lot Numbers: 2023041089; ee) Model Number 91246, GTIN 20613994887539, Lot Numbers: 2023041089, 202306C101; ff) Model Number 91246C, GTIN 00613994887528, Lot Numbers: 2023041090; ff) Model Number 91246C, GTIN 20613994887522, Lot Numbers: 2023041090, 202306C123; gg) Model Number 91236C, GTIN 00613994887344, Lot Numbers: 2023041072; gg) Model Number 91236C, GTIN 20613994887348, Lot Numbers: 2023041072, 202306C065; hh) Model Number 91251, GTIN 00613994887498, Lot Numbers: 2023041092, 2023041094; hh) Model Number 91251, GTIN 20613994887492, Lot Numbers: 2023041092, 2023041094; ii) Model Number 91251C, GTIN 00613994887481, Lot Numbers: 2023040618, 202306C102; ii) Model Number 91251C, GTIN 20613994887485, Lot Numbers: 2023040617, 2023040618, 202306C102; jj) Model Number 93438, GTIN 00673978188201, Lot Numbers: 2023040626; jj) Model Number 93438, GTIN 20613994887034, Lot Numbers: 2023040626; kk) Model Number 93448C, GTIN 20613994887256, Lot Numbers: 2023040627

Distribution pattern

Worldwide distribution.