Medline General Endoscopy Procedure Kit Recalled Due to Syringe Defects
Medline is recalling General Endoscopy procedure kits due to plastic syringe defects that may leak or break. The affected kits pose potential risk to patient health during medical procedures.
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: Class II recall of medical device kit. The syringe defects (leaks, breakage) in a sterile procedure kit present risk of compromised patient care. No illnesses or injuries reported, which per the severity rubric limits classification to High.
Plain-English summary
Medline Industries is recalling General Endoscopy procedure kits (Pack Number DYNJ44673G) due to plastic syringe defects. The syringes are affected by an FDA Safety Alert issued March 19, 2024, and have been identified to have leaks, breakage, and other quality issues that may pose a risk to patient health.
The affected kit has lot number 22KDC145A and has been distributed worldwide, including throughout the United States and Canada.
The recalled product
- Product
- Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 30
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) Pack Number DYNJ44673G: UDI/DI 10195327127473 (each) 40195327127474 (case)
- Lot Number 22KDC145A
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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