Gambro Recalls Prisma M60 Postdilution Sets Due to Connector Breakage
Gambro Renal Products is recalling Prisma M60 POSTDILUTION sets because connector breakages can cause leakage of liquid or blood.
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 defect (connector breakage) that poses a risk of harm (leakage of blood or liquid) to patients, 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 M60 POSTDILUTION sets, product number 104183. The affected units are packaged in plastic pouches, with four pouches per carton box. The specific batch number is 13C2103, with an expiry date of 03/2015.
The recall was initiated due to breakages of connectors on the sets, which can result in the leakage of liquid or blood. A total of 401,451 units were distributed worldwide.
Healthcare facilities and users should stop using the affected Prisma M60 POSTDILUTION sets immediately and contact Gambro Renal Products for instructions on return or replacement.
The recalled product
- Product
- Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Manufacturer
- Gambro Renal Products, Incorporated
- 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.
See all 15 products in this recall →Related recalls
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