Medline CV Neonatal Procedure Kits Recalled Due to Syringe Quality Issues
Medline is recalling CV Neonatal Pack procedure kits (Pack Number DYNJ67356) because the plastic syringes may leak or break, potentially harming patients. The recall affects 96 units distributed nationwide and in Canada.
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: FDA Class II recall of medical procedure kits containing syringes with quality defects (leaks, breakage) that pose a risk to patient health. No illnesses, injuries, or hospitalizations are reported in the source text, meeting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling CV Neonatal Pack procedure kits (Pack Number DYNJ67356, Lot Number 23GMF016A) containing plastic syringes affected by an FDA Safety Alert from March 19, 2024. A total of 96 units were distributed nationwide in the United States and in Canada.
The plastic syringes in these kits have quality issues including leaks and breakage that may pose a risk to patient health. These defects were identified as part of the FDA Safety Alert issued on the affected syringes.
Patients and healthcare providers who have received these kits should stop using them immediately. Contact Medline Industries for instructions on return or disposal, or consult with your healthcare provider if you have questions about this recall or have already used these kits.
The recalled product
- Product
- Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 96
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 DYNJ67356: UDI/DI 10193489887136 (each) 40193489887137 (case)
- Lot number 23GMF016A
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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