Medline Ultrasound Breast Pack Recalled for Potential Sterility Breach
Medline is recalling 300 Ultrasound Breast Packs due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and the source text explicitly reports potential health consequences including hospitalization and life-threatening infection, meeting the criteria for a Severe rating.
Plain-English summary
Medline Industries, LP is recalling 300 Ultrasound Breast Packs (Model Number: DYNJ63375C) distributed nationwide in the United States. The recall is due to a potential breach of sterility in the packaging of the included BD ChloraPrep Clear and FREPP Clear applicators. Wrinkles in the paper lidding may extend to the seal area, compromising the sterile barrier.
If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences range from no injury to localized infection or more serious infections requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, severe infection could become life-threatening, particularly in critically ill or immunocompromised patients.
The affected product is identified by Lot Number 23LMC035 and UDI-DI 10193489851823 (each) or 40193489851824 (case). Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product if it matches the description.
The recalled product
- Product
- Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C
- Manufacturer
- Medline Industries, LP
- Affected units
- 300
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)
- 1) DYNJ63375C
- UDI-DI: 10193489851823(each)
- 40193489851824(case)
- Lot Number: 23LMC035
Distribution
Distributed nationwide across the United States.
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