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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: August 13, 2014
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Affected Products

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Lot Numbers:
0000017412
Product: X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541

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

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68788
Status: Resolved
Manufacturer: Gambro Renal Products, Incorporated
Manufactured In: United States
Units Affected: 15 products (401,451)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.