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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97604

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

Open FDA event record

Event summary

Timeline bucket
August 29, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Baxter Healthcare Corporation

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

16 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 16

CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255

Z-0189-2026
Recall number
Z-0189-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
49200

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412046310, Lot numbers: R25C26161 and R25D01031

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 2 of 16

CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419

Z-0190-2026
Recall number
Z-0190-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
136512

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI: 00085412048956,Lot Codes: R25C03055, R25C04062, and R25C29086

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 3 of 16

CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425

Z-0191-2026
Recall number
Z-0191-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
1440

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412071190, Lot numbers: R25C27086

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 4 of 16

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519

Z-0192-2026
Recall number
Z-0192-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
473040

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412048994, Lot numbers: R25A25147, R25B21086, R25C20130, R25C25055, R25C25161, and R25C29185

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 5 of 16

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537

Z-0193-2026
Recall number
Z-0193-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
958351

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412048970, Lot numbers: R25A13055, R25B24024, R25B25154, R25C05017, R25C13147, R25C18017, R25C18024, R25C25116, R25C26093, R25C31079, R25D03055, R25D12123, R25D19024

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 6 of 16

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541

Z-0194-2026
Recall number
Z-0194-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
1167120

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412071107, Lot numbers: R25A17123, R25B20048, R25B21024, R25B24093, R25B26154, R25B27123, R25B27161, R25C04055, R25C05048, R25C05109, R25C06123, R25C08154, R25C10079, R25C11062, R25C18093, R25D12208, R25D21024.

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 7 of 16

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571

Z-0195-2026
Recall number
Z-0195-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
106176

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412046327, Lot numbers: R25B24055

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 8 of 16

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593

Z-0196-2026
Recall number
Z-0196-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
8368

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412071664, Lot numbers:R25D01161

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 9 of 16

CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610

Z-0197-2026
Recall number
Z-0197-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
15552

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412048963, Lot numbers: R25C31024

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 10 of 16

CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632

Z-0198-2026
Recall number
Z-0198-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
2304

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412049007, Lot numbers: R25C31031

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 11 of 16

CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634

Z-0199-2026
Recall number
Z-0199-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
16416

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412049021, Lot numbers: R25A21024

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 12 of 16

CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603

Z-0200-2026
Recall number
Z-0200-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
69936

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412046433, Lot numbers: R25C26154 and R25C27079

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 13 of 16

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519

Z-0201-2026
Recall number
Z-0201-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
48096

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412565682, Lot numbers: R25C26116

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 14 of 16

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537

Z-0202-2026
Recall number
Z-0202-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
12720

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412565743, Lot numbers: R25C28048

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 15 of 16

CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858

Z-0203-2026
Recall number
Z-0203-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
27072

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UDI/DI 00085412565774, Lot numbers: R25A13024

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

device · product 16 of 16

CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519

Z-0204-2026
Recall number
Z-0204-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Quantity
18720 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IV sets may leak.

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

IV sets may leak.

Code information

UID/DI 00085412625553, Lot numbers: R25C08147

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.