Z-2194-2014Class II

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

Name: Z-2194-2014 Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
Creator: Gambro Renal Products, Incorporated
Published: 2014-07-18
License: https://open.fda.gov/license/

Gambro Renal Products / initiated 2014-07-18 / Terminated / root cause: design

FDA source

Gambro Renal Products, Incorporated began a recall of Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box on 2014-07-18. FDA classified it as Class II and gives the reason as "Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2194-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-18
Posted: 2014-08-13
Terminated: 2015-02-05
Recalling firm: Gambro Renal Products
Product: Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
Product code: MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
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.
Root cause tag: design
FDA root cause: Device Design
Action: Gambro sent an Urgent Field Safety Notice dated July 18, 2014 to all end-users. A Customer Reply Form was attached to the notice for customers to complete and return.
Quantity in commerce: 401,451
Distribution: Worldwide Distribution.
Product codes and lots: Prisma TPE 2000 set. Product number 109672. Batch number 12B0607. Expiry 02/2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2194-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2193-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2194-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2195-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2196-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2197-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2198-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2199-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2200-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2201-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2202-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2203-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2204-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2205-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2206-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13
Z-2207-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13

Product code MDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)