Exact FDA event identifier

Event 68788

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

Event summary

Timeline bucket: July 18, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Gambro Renal Products, Incorporated

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

15 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 15

Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2193-2014

Recall number: Z-2193-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Product Number 1071441. Batch number 12A1905 to 14C1706. Expiry date 01/2015 to 03/2017.

Distribution pattern

Worldwide Distribution.

device · product 2 of 15

Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2194-2014

Recall number: Z-2194-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Prisma TPE 2000 set. Product number 109672. Batch number 12B0607. Expiry 02/2015.

Distribution pattern

Worldwide Distribution.

device · product 3 of 15

Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2195-2014

Recall number: Z-2195-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016.

Distribution pattern

Worldwide Distribution.

device · product 4 of 15

Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2196-2014

Recall number: Z-2196-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Prisma M60 POSTDILUTION set. Product number 104183. Batch number 13C2103. Expiry 03/2015.

Distribution pattern

Worldwide Distribution.

device · product 5 of 15

Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2197-2014

Recall number: Z-2197-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Prisma M 100 PRE set. Product number 103657. Batch number 12A0302G to 14B2102. Expiry 01/2014 to 02/2016

Distribution pattern

Worldwide Distribution.

device · product 6 of 15

Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2198-2014

Recall number: Z-2198-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Prisma M100 set. Product number 104182. Batch number 12A3005 to 14A1703. Expiry 01/2014 to 01/2016

Distribution pattern

Worldwide Distribution.

device · product 7 of 15

Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2199-2014

Recall number: Z-2199-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Prisma M100 PRE pump infusion set. Product number 107791. Batch number 12A2305 to 13D0902. Expiry 01/2014 to 04/2015

Distribution pattern

Worldwide Distribution.

device · product 8 of 15

Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2200-2014

Recall number: Z-2200-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Prisma HF1000 preset (new design). Product number 107639. Batch number 12A1303 to 13E3104. Expiry 01/2014 to 05/2015

Distribution pattern

Worldwide Distribution.

device · product 9 of 15

Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2201-2014

Recall number: Z-2201-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Prismaflex M60 set. Product number 106696. Batch number 12A0605 to 14A2011. Expiry 01/2014 to 01/2016

Distribution pattern

Worldwide Distribution.

device · product 10 of 15

Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2202-2014

Recall number: Z-2202-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Prismaflex M100. Product number 106697. Batch number 12A0401G to 14C2802G. Expiry 01/2014 to 03/2016

Distribution pattern

Worldwide Distribution.

device · product 11 of 15

Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2203-2014

Recall number: Z-2203-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Prismaflex M150. Product number 109990. Batch number 12A0304G to 14C2706. Expiry 01/2014 to 03/2016

Distribution pattern

Worldwide Distribution.

device · product 12 of 15

Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2204-2014

Recall number: Z-2204-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Prismaflex HF 1000. Product number 107140. Batch number 12A0504 to 14C3105. Expiry 01/2014 to 03/2016

Distribution pattern

Worldwide Distribution.

device · product 13 of 15

Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2205-2014

Recall number: Z-2205-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Prismaflex HF 1400. Product number 107142. Batch number 12A1005 to 14C1106. Expiry 01/2014 to 03/2016

Distribution pattern

Worldwide Distribution.

device · product 14 of 15

PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch

Z-2206-2014

Recall number: Z-2206-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Model Number MARS Treatment Kit Type 1115/1 PrisMARS US, Batch 0000017412 - 0000019827, Expiry Date 06/2014 to 05/2016

Distribution pattern

Worldwide Distribution.

device · product 15 of 15

X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541

Z-2207-2014

Recall number: Z-2207-2014
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Gambro Renal Products, Incorporated
Quantity: 401,451

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Code information

Model Number MARS Treatment Kit Type 1116/1 X-MARS US, Batch Number 0000020229, Expiry Date 02/2017

Distribution pattern

Worldwide Distribution.