Gambro Recalls Prismaflex TPE 2000 Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex TPE 2000 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 risk of harm (leakage of blood or liquid) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Gambro Renal Products, Incorporated is recalling Prismaflex TPE 2000 sets, Product Number 1071441. The affected units are packaged in plastic pouches, with four pouches per carton box.
The recall was initiated due to breakages of connectors, which can result in the leakage of liquid or blood. The source text does not specify the number of affected units, specific distribution locations, or reported injuries.
Consumers and healthcare facilities should stop using the affected product and contact Gambro Renal Products for further instructions.
The recalled product
- Product
- Prismaflex TPE 2000 set, Product Number 1071441. 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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