Medical Specialties Distributors Recalls Leaking Medstream Infusion Sets
Medical Specialties Distributors is recalling Medstream 81-inch infusion sets that may leak at the Y-site. The recall covers 472 cases distributed nationwide.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (leaking sterile infusion set) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medical Specialties Distributors, Inc. is recalling Medstream 81-inch (206 cm) 20 Drop Standard bore Universal Administration Sets with Y-Site, sterile, manufactured in China. The product is a disposable infusion set, product number MS721, manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA). The recall involves 472 cases (50 units per case) with lot number 20111115.
The recall was initiated because the devices are leaking at the Y-site. This defect could compromise the integrity of the sterile administration set during use.
The affected products were distributed nationwide. Consumers and healthcare facilities should stop using the recalled infusion sets and contact Medical Specialties Distributors, Inc. for further instructions or a return.
The recalled product
- Product
- Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set
- Manufacturer
- Medical Specialties Distributors, Inc.
- Category
- Medical Device — Infusion Set
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 NUMBER: 20111115
Distribution
Distributed nationwide across the United States.
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