Sterile Procedural Trays Recalled Due to Potential Packaging Puncture
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer packaging foil, potentially compromising sterility. No injuries have been reported.
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 Class II recall involves a potential breach of sterile packaging through blade puncture, which is a risk-of-harm in a medical device context. However, no injuries or illnesses have been reported and the hazard is theoretical rather than confirmed, placing it at the High level per the rubric.
Plain-English summary
Medline Industries, LP is recalling Sterile Procedural Trays labeled as MINOR BASIC PACK-LF. The recalled trays were distributed worldwide, including throughout the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. The recall affects 50 cases containing 200 units total, with lot numbers 22JMA630 and 22HMC805.
The recall was issued because sterile blades within the procedural kits have the potential to puncture the outer foil layer of the sterile packaging. This puncture could compromise the sterility of the medical device.
No injuries or illnesses related to this issue have been reported to date. Patients and healthcare providers who have received these trays should contact Medline Industries or their healthcare facility if they have questions about whether they have affected product.
The recalled product
- Product
- Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
- blade-puncture
- sterility-compromise
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 (5)
- Item Number: DYNJ0281516M
- Case UDI/GTIN: 40889942056676
- Unit UDI/GTIN: 10889942056675
- Lot Number: 22JMA630
- 22HMC805
Distribution
Distributed nationwide across the United States.
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