Molded Products Recalls Non-Sterile Hemodialysis Tubing Connectors
Molded Products Inc is recalling 400 non-sterile hemodialysis tubing connectors due to a reported leak. The product was distributed to Ontario, Canada.
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 used in hemodialysis where a leak was reported. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not an FDA Class I recall.
Plain-English summary
Molded Products Inc is recalling 400 pieces of Non-Sterile Double DIN to DIN "Y" Connectors. These products are used as extensions for connecting hemodialysis blood tubing to the hemodialyzer. The recall was initiated after a customer reported a complaint regarding a leaking dialysis tubing connector.
The affected product was distributed to Ontario, Canada. The source text does not specify the exact date of distribution or the specific facilities where the product was used.
Consumers and healthcare facilities should stop using the affected connectors immediately. The source text does not provide specific instructions for disposal or return, but users should contact the manufacturer or their medical device supplier for further guidance.
The recalled product
- Product
- Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.
- Manufacturer
- Molded Products Inc
- Hazard
- Affected units
- 400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 40013
Distribution
Distribution scope not specified by the agency.
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