Baxter Healthcare Corporation: Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

Recall number

Z-1279-2021

Recalling firm

Baxter Healthcare Corporation

Product

Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

Status

Terminated

Initiated

2021-01-28

Posted

not on file

Terminated

2024-06-13

Reason

Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

Root cause

Process control

Action

An Urgent Medical Device Correction communication and reply form were sent to affected customers via U.S.P.S., first class mail on January 28, 2021.

Quantity

1650 units

Distribution

Worldwide distribution - US Nationwide distribution including Puerto Rico and Guam and the countries of Albania, Algeria, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxemburg, Macedonia, Malta, Mauritius, Montenegro, Morocco, Netherlands, Nigeria, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sudan, Syria, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Yemen, Australia, New Zealand, China, Japan, Korea, Taiwan, Hong Kong, India, Thailand, Singapore, Malaysia, Vietnam, Grand Cayman, Dominican Republic, St. Kitts, Venezuela, Argentina, Chile, Barbados, Bermuda, Costa Rica, Cuba, Haiti, Guatemala, Colombia, Trinidad & Tobago, Mexico, and Brazil.

Lot, serial or model codes

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PA15875, PA15874, PA15873, PA15872, PA15871, PA15870, PA15869; GTIN 07332414124236 (product code 955542), serial numbers PA20340, PA20298, PA20297, PA20296, PA20291, PA20290, PA20289, PA20288, PA20287, PA20286, PA20284, PA20283, PA20282, PA20280, PA20279, PA20278, PA20277, PA20276, PA20275, PA20274, PA20273, PA20272, PA20271, PA20270, PA20269, PA20268, PA20267, PA20266, PA20265, PA20264, PA20263, PA20262, PA20261, PA20260, PA20259, PA20258, PA20252, PA20247, PA20246, PA20245, PA20244, PA20243, PA20190, PA20189, PA20188, PA20187, PA20179, PA20178, PA20177, PA20176, PA20175, PA20174, PA20173, PA20172, PA20171, PA20170, PA20169, PA20168, PA20167, PA20166, PA20165, PA20163, PA20146, PA20135, PA20134, PA20133, PA20132, PA20131, PA20130, PA20129, PA20128, PA20127, PA20126, PA20125, PA20124, PA20123, PA20122, PA20121, PA20120, PA20119, PA20118, PA20117, PA20115, PA20114, PA20113, PA20112, PA20111, PA20110, PA20109, PA20108, PA20107, PA20106, PA20105, PA20104, PA20102, PA20101, PA20100, 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PA22786, PA22787, PA22783, PA22862, PA22860, PA22861.

510(k) numbers

["K131516"]

PMA numbers

not on file

Product code

KDI

Firm FEI

1417572

Firm city

Deerfield

Firm state

IL

Firm country

not on file

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

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