Sterile Trach Pack procedure kits recalled due to blade puncture risk
Medline Industries is recalling TRACH PACK sterile procedure kits because sterile blades within the kits can puncture the outer foil packaging, potentially compromising product 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 with no reported illnesses or injuries. The hazard is theoretical—potential for blade puncture to compromise sterility. Per the rubric, risk-of-harm products where injury has not yet been reported score as High.
Plain-English summary
Medline Industries, LP is recalling TRACH PACK Sterile Procedural Trays. These are sterile kits containing supplies and instrumentation for tracheotomy procedures.
The recall was initiated because sterile blades within the kits have the potential to puncture the outer foil layer of the sterile packaging, which is designed to maintain product sterility.
The affected products include lot numbers 22JMB321, 22JMA904, and 22HMD287. These kits were distributed worldwide, including the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and United Arab Emirates, with a total of 28 cases (112 units) affected.
Individuals and facilities with these kits should contact Medline Industries regarding this recall.
The recalled product
- Product
- TRACH PACK. Sterile Procedural Tray.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- blade-puncture
- sterile-package-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 (6)
- Item Number: DYNJ46518G
- Case UDI/GTIN: 40195327009169
- Unit UDI/GTIN: 10195327009168
- Lot Number: 22JMB321
- 22JMA904
- 22HMD287
Distribution
Distributed nationwide across the United States.
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