Molded Products Recalls Sterile Hemodialysis Line Sets Due to Leaks
Molded Products Inc is recalling 1,200 sterile access and return line sets used in hemodialysis because they leak at the connection site.
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 used in hemodialysis that leaks, posing a risk of harm (infection or procedural failure) even though no specific injuries are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Molded Products Inc is recalling 1,200 sets of Sterile Access & Return Line Sets, 36" Length, Part # UM-872-36. The product is intended for use with medically prescribed hemodialysis blood tubing. The recall affects lot numbers 80106 and 80106b.
The recall was initiated because the recalled product leaks at the connection site. This defect could compromise the sterile environment required for hemodialysis procedures.
The affected units were distributed to one customer in Michigan. No specific dates or additional distribution details are provided in the source text.
The recalled product
- Product
- Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
- Manufacturer
- Molded Products Inc
- Hazard
- Affected units
- 1,200
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)
- Lot numbers: 80106 and 80106b
Distribution
Distributed in 1 state:
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