Medline Procedure Kits with Defective Syringes Recalled for Leak and Breakage Risk
Medline is recalling C SCOPE Disposable Kits due to plastic syringes affected by quality issues including leaks and breakage that may pose a risk to patient health. The recall affects kits distributed nationwide in the US and 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: This is a Class II medical device recall involving identified functional defects (leaks and breakage) in syringes used for medical procedures. The defects pose a risk of patient harm, and no illnesses or injuries have been reported, placing this in the High severity category per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling C SCOPE Disposable Kits (Pack Numbers 613034700 and 613034702) containing plastic syringes affected by quality issues. These syringes are part of an FDA Safety Alert issued on March 19, 2024, related to leaks, breakage, and other quality defects.
The affected kits were distributed nationwide in the United States and in Canada. The recall involves lot numbers 613034700 and 613034702, affecting approximately 90 units total.
These quality issues in the syringes—specifically leaks and breakage—may pose a risk to patient health when the kits are used for medical procedures.
The recalled product
- Product
- Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kit
- Affected units
- 90
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 (4)
- 1) Pack Number 613034700: UDI/DI 10850009724004 (each) 40850009724005 (case)
- Lot Number 613034700
- 2) Pack Number 613034702: UDI/DI 10850009724066 (each) 40850009724067 (case)
- Lot Number 613034702
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by MEDLINE INDUSTRIES, LP - Northfield 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.
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