Medline Esophagectomy Convenience Kits Recalled for Syringe Leaks and Breakage
Medline Industries recalls esophagectomy convenience kits containing plastic syringes with leaks and breakage issues. The defects may pose 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 recall of medical convenience kits with identified physical defects (leaks and breakage) in surgical syringes. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Medline Industries, LP is recalling medical convenience kits labeled as PUH ESOPHAGECTOMY CDS (Pack Number CDS984309I, Lot Number 22DBK534) due to quality defects in the included plastic syringes.
The plastic syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. Identified issues include leaks, breakage, and other quality problems that may pose a risk to patient health during use.
The convenience kits have been distributed worldwide. Healthcare facilities that may have received these products are advised to consult the FDA's official recall notice and contact Medline Industries for specific guidance on affected inventory and appropriate next steps.
The recalled product
- Product
- Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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)
- CDS984309I
- Lot Number 22DBK534
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 81 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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