PlainRecalls

Gambro Renal Products, Incorporated

15 recalls on record · Latest: Aug 20, 2014

Gambro Renal Products, Incorporated Recall Insight

Gambro Renal Products, Incorporated appears on 15 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.018% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Aug 20, 2014, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 15 entries, severity tagging shows 0 critical, 15 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 15 of 15 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (15). The date window on this page runs from Apr 23, 2014 to Aug 20, 2014.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Aug 20, 2014

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

FDA Devices Moderate Aug 20, 2014

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

FDA Devices Moderate Aug 20, 2014

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

FDA Devices Moderate Aug 20, 2014

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

FDA Devices Moderate Aug 20, 2014

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

FDA Devices Moderate Aug 20, 2014

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

FDA Devices Moderate Aug 20, 2014

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

FDA Devices Moderate Aug 20, 2014

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

FDA Devices Moderate Aug 20, 2014

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

FDA Devices Moderate Aug 20, 2014

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

FDA Devices Moderate Aug 20, 2014

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

FDA Devices Moderate Aug 20, 2014

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

FDA Devices Moderate May 28, 2014

Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic ren…

FDA Devices Moderate May 28, 2014

Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal fa…

FDA Devices Moderate Apr 23, 2014

Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003…

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds