Sterile Procedural Trays Recalled Over Potential Blade Puncture of Packaging
Medline Industries is recalling sterile procedural trays because sterile blades inside could puncture the outer foil packaging, compromising sterility. The recall affects units distributed worldwide.
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: This recall affects a sterile medical device where a defect could compromise sterility. While no illnesses or injuries have been reported, the potential for contamination from a breached sterile package represents a risk-of-harm product without reported injury, meeting the rubric criterion for High severity.
Plain-English summary
Medline Industries, LP is recalling the UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Trays due to a product defect. The sterile blades contained within the sterile kits have the potential to puncture the outer foil layer of the sterile packaging. If the protective foil is compromised, the sterility of the tray cannot be assured, creating a risk of contamination for surgical use.
The affected product has been distributed worldwide, including throughout the United States, Canada, Japan, Mexico, Panama, Turks and Caicos, and the United Arab Emirates. The recalled lot is identified by Lot Number 22IBJ862, with Item Number DYNJ52230. A total of 20 cases containing 120 units have been recalled.
Patients and healthcare providers who have these trays should not use them. Facilities should identify and quarantine any remaining inventory of the affected lot and return it to Medline Industries or their distributor.
The recalled product
- Product
- UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- puncture
- sterility-breach
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: DYNJ52230
- Case UDI/GTIN: 40889942252269
- Unit UDI/GTIN: 10889942252268
- Lot Number: 22IBJ862
Distribution
Distributed nationwide across the United States.
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