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Moderate riskFDA DeviceClass II

Medline Ultrasound Breast Pack recalled for sterility packaging breach in applicators

Medline's Ultrasound Breast Pack (Model DYNJ63375C) contains sterilized applicators with wrinkles in the paper packaging that may compromise the sterile barrier. If the packaging is damaged, the applicators could be exposed to microbial contamination before use.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Check if you have lot 23LMC035 of this product
  2. Do not use affected kits; contact Medline Industries with your lot number for instructions
  3. Watch for signs of infection at the application site; seek medical care if infection develops
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C
Sold in
Nationwide
Made for
Adults

This recall covers 16 products — see all of them.

Details

Units affected
300 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class II
Recall number
Z-3053-2026

In the FDA's words

Description
Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening. 1) DYNJ63375C, UDI-DI: 10193489851823(each), 40193489851824(case), Lot Number: 23LMC035 Distribution: US Nationwide distribution. Affected quantity: 300 kits
Hazard
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

16 products in this recall

Medline convenience kits recalled for possible sterility breach

Medline is recalling 16 convenience kit products that contain BD ChloraPrep Clear or FREPP Clear antiseptic applicators. Wrinkles in the paper lidding may extend to the seal, which could break the sterile packaging and allow microbial contamination. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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