Gambro Recalls Prisma TPE 2000 Sets Due to Connector Breakage
Gambro Renal Products is recalling Prisma TPE 2000 sets because connector breakages can cause liquid or blood leakage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect (connector breakage) that poses a risk of harm (leakage of blood/liquid), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Gambro Renal Products, Incorporated is recalling Prisma TPE 2000 sets (Product number 109672). The recall involves 401,451 units that were distributed worldwide. Each set is packaged in a plastic pouch, with 4 pouches per carton box.
The field action was initiated due to breakages of connectors, which can result in the leakage of liquid or blood. The specific batch number is 12B0607, with an expiry date of 02/2015.
Healthcare providers and consumers should stop using these specific sets and contact Gambro Renal Products for further instructions or replacement.
The recalled product
- Product
- Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Manufacturer
- Gambro Renal Products, Incorporated
- Hazard
- Affected units
- 401,451
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Gambro Renal Products, Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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