Medline Recalls Sterile Piston Irrigation Syringe Trays Due to Packaging Defects
Medline Industries is recalling 11,962 sterile piston irrigation syringe trays because samples showed incomplete or open packaging seals.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves packaging integrity without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medline Industries Inc is recalling 11,962 units of Sterile Piston Irrigation Syringe Tray with Saline (Reference DYNC2303). The recall affects Lot Number 19CAB954, which was distributed nationwide in the United States.
The recall was initiated because samples from the identified lot were found to have incomplete or open packaging seals. This defect may compromise the sterile integrity of the medical device.
Healthcare facilities and consumers who have this specific lot of syringe trays should stop using them and contact Medline Industries for further instructions or a return.
The recalled product
- Product
- Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Syringes
- Affected units
- 11,962
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 (1)
- Lot Number 19CAB954
Distribution
Distributed nationwide across the United States.
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