Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling Sterile Procedural Trays (LS MS PACK) because the sterile blade inside can potentially puncture the outer packaging layer, compromising sterility.
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 for a risk-of-harm product where the sterile blade can potentially compromise packaging integrity and product sterility. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed.
Plain-English summary
Medline Industries, LP is recalling Sterile Procedural Trays labeled LS MS PACK. The sterile blade within these kits has the potential to puncture the outer foil layer of the sterile packaging.
The affected product consists of 159 cases distributed worldwide. Distribution includes the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. The recalled product is identified by Lot Number 22IBO057 and Item Number DYNJ81738.
The recalled product
- Product
- Sterile Procedural Trays, labeled as the following: LS MS 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: DYNJ81738
- Case UDI/GTIN: 40195327138258
- Unit UDI/GTIN: 10195327138257
- Lot Number: 22IBO057
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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