Exact FDA event identifier

Event 87150

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

Event summary

Timeline bucket: December 30, 2020
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

6 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 6

Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Z-1118-2021

Recall number: Z-1118-2021
Initiated: December 30, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 7437480 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Code information

UDI 07332414007836, All lots within expiry

Distribution pattern

Worldwide distribution.

device · product 2 of 6

Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Z-1119-2021

Recall number: Z-1119-2021
Initiated: December 30, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 385 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Code information

UDI 07332414007881, All lots within expiry

Distribution pattern

Worldwide distribution.

device · product 3 of 6

Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Z-1120-2021

Recall number: Z-1120-2021
Initiated: December 30, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 1460 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Code information

UDI 07332414007812, All lots within expiry

Distribution pattern

Worldwide distribution.

device · product 4 of 6

Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Z-1121-2021

Recall number: Z-1121-2021
Initiated: December 30, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 211155 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Code information

UDI 07332414085216, All lots within expiry

Distribution pattern

Worldwide distribution.

device · product 5 of 6

Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Z-1122-2021

Recall number: Z-1122-2021
Initiated: December 30, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 57825 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Code information

UDI 07332414112394, All lots within expiry

Distribution pattern

Worldwide distribution.

device · product 6 of 6

Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Z-1123-2021

Recall number: Z-1123-2021
Initiated: December 30, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 25785 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Code information

UDI 07332414112400, All lots within expiry

Distribution pattern

Worldwide distribution.