Medline Procedural Trays Recalled for Blade Packaging Risk
Medline Industries is recalling Ambulatory Mini Pack sterile procedural trays because blades within the kits may puncture the outer sterile packaging, potentially compromising sterility.
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: This Class II medical device recall involves a manufacturing defect where sterile blades may puncture the sterile packaging barrier, compromising sterility and creating a risk of infection. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP (Northfield) is recalling Ambulatory Mini Pack Sterile Procedural Trays due to a manufacturing defect. The recall affects 36 cases containing 216 units, identified by Item Number DYNJ82579, Case UDI/GTIN 40195327198153, Unit UDI/GTIN 10195327198152, and Lot Number 22HBQ045.
The sterile blades within these procedural trays have the potential to puncture the outer foil layer of the sterile packaging. A puncture could compromise the sterile barrier and allow contamination of the medical device, creating a risk of infection if the tray is used for a medical procedure.
The affected trays were distributed worldwide, including throughout the United States and to Canada, Japan, Mexico, Panama, Turks and Caicos, and the United Arab Emirates.
Healthcare facilities and patients in possession of these trays should stop using them immediately and contact Medline Industries for replacement or disposal instructions.
The recalled product
- Product
- Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
- 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 (4)
- Item Number: DYNJ82579
- Case UDI/GTIN: 40195327198153
- Unit UDI/GTIN: 10195327198152
- Lot Number: 22HBQ045
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 38 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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