FDA Medical Device Recalls (openFDA)
Gambro Renal Products, Incorporated: Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Recall number
- Z-2193-2014
- Recalling firm
- Gambro Renal Products, Incorporated
- Product
- Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Status
- Terminated
- Initiated
- 2014-07-18
- Posted
- 2014-08-13
- Terminated
- 2015-02-05
- Reason
- 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
- 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
- 401,451
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- Product Number 1071441. Batch number 12A1905 to 14C1706. Expiry date 01/2015 to 03/2017.
- 510(k) numbers
- not on file
- PMA numbers
- ["P830063S006"]
- Product code
- MDP
- Firm FEI
- 1713683
- Firm city
- Lakewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28