Medline C-Section Procedure Kits Recalled for Defective Syringes
Medline is recalling 456 C-section procedure kits containing plastic syringes affected by an FDA safety alert. The syringes may leak or break, posing a risk to patient health during surgical procedures.
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: FDA Class II medical device recall involving defective syringes in surgical procedure kits with potential for leakage or breakage that could compromise sterility and patient safety. No illnesses or injuries have been reported, but the hazard presents significant risk in surgical settings.
Plain-English summary
Medline Industries, LP is recalling 456 procedure kits labeled as C SECTION (Pack Number DYNJ909098) distributed in the United States and Canada. The kits contain plastic syringes that are subject to an FDA Safety Alert issued on March 19, 2024, regarding quality defects.
The affected syringes may leak, break, or exhibit other quality issues that could compromise their sterility or function during use. These defects may pose a risk to patient health, particularly in surgical settings where sterile equipment is critical to procedure safety.
This recall affects healthcare facilities that received and may be using affected kits from the distributed lot. The affected lot number is 23GBK039Z, with lot codes 10195327273132 (individual) and 40195327273133 (case).
Healthcare providers who have received these kits should stop using them immediately and contact Medline Industries or the FDA for replacement options. Affected kits should be removed from use and properly handled according to facility protocols for recalled medical devices.
The recalled product
- Product
- Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 456
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 (2)
- 1) 10195327273132 (each) 40195327273133 (case)
- Lot Number 23GBK039Z
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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