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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85514

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

Open FDA event record

Event summary

Timeline bucket
April 17, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
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

4 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 4

Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.

Z-2193-2020
Recall number
Z-2193-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Quantity
2,361,885 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential disconnection of tubing set.

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 disconnection of tubing set.

Code information

Product Code: 101025; UDI: 37332414007837; Lot Numbers: 1000200708, 1000203117, 1000203118, 1000203119, 1000203120, 1000203121, 1000205678, 1000205897, 1000205898, 1000205899, 1000205900, 1000205901, 1000206872, 1000206873, 1000206874, 1000208247, 1000208248, 1000208249, 1000208250, 1000210314, 1000210315, 1000210316, 1000210317, 1000210318, 1000210319, 1000210320, 1000211719, 1000211720, 1000211721, 1000211722, 1000211723, 1000211724, 1000215485, 1000215486, 1000215487, 1000215488, 1000215489, 1000215490, 1000217361, 1000217362, 1000217363, 1000217364, 1000218866, 1000218867, 1000218868, 1000218869, 1000218870, 1000218871, 1000220529, 1000220530, 1000220531, 1000220532, 1000223070, 1000223071, 1000223072, 1000223073, 1000223074, 1000225427, 1000225428, 1000225429, 1000225430, 1000225431, 1000226714, 1000226717, 1000229599

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lithuania, Latvia, Montenegro, Morocco, Netherlands, Norway, Poland, Russia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, Korea, Singapore, Hong Kong

device · product 2 of 4

Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.

Z-2194-2020
Recall number
Z-2194-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Quantity
53,895 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential disconnection of tubing set.

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 disconnection of tubing set.

Code information

Product Code: 109536; UDI: 37332414085217; Lot Numbers: 1000205902, 1000214627, 1000222392, 1000226807

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lithuania, Latvia, Montenegro, Morocco, Netherlands, Norway, Poland, Russia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, Korea, Singapore, Hong Kong

device · product 3 of 4

Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.

Z-2195-2020
Recall number
Z-2195-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Quantity
19,800 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential disconnection of tubing set.

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 disconnection of tubing set.

Code information

Product Code: 114434; UDI: 47332414112395; Lot Numbers: 1000201510, 1000206870, 1000214235, 1000218202, 1000224530

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lithuania, Latvia, Montenegro, Morocco, Netherlands, Norway, Poland, Russia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, Korea, Singapore, Hong Kong

device · product 4 of 4

Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.

Z-2196-2020
Recall number
Z-2196-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Quantity
4,065

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential disconnection of tubing set.

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 disconnection of tubing set.

Code information

Product Code: 114435; UDI: 37332414112401; Lot Numbers: 1000212228, 1000215484, 1000224531

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lithuania, Latvia, Montenegro, Morocco, Netherlands, Norway, Poland, Russia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, Korea, Singapore, Hong Kong