Gambro Recalls Prisma M 60 PRE Sets Due to Connector Breakage
Gambro Renal Products is recalling Prisma M 60 PRE sets because connector breakages can cause leakage of liquid or blood.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 or liquid), but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Gambro Renal Products, Incorporated is conducting a field action on Prisma and Prismaflex sets, specifically the Prisma M 60 PRE set (new design), product number 103658. The action is being taken due to breakages of connectors that can result in the leakage of liquid or blood.
The affected units are identified by batch numbers 12K1205G to 14B1003 and have expiry dates ranging from 11/2014 to 02/2016. The source text indicates that 401,451 units were distributed worldwide.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units or what to do if they have already used them.
The recalled product
- Product
- Prisma M 60 PRE set (new design). Product number 103658. 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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