Medline Recalls Sterile Elastic Esmark Bandages Due to Sterilization Failure
Medline Industries is recalling 5,722 units of sterile elastic bandages because they may not have been properly sterilized.
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: The recall involves a medical device that may be non-sterile, posing a risk of infection. No illnesses or injuries are reported in the source text, and the agency classification is Class II, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries Inc is recalling 5,722 units of Sterile Elastic Esmark Bandages, 3" x 9" (Model No. DYNJ05914). The affected lots are 17GB3101, 172B2025, 17FB9612, and 17QB8614. The bandages are individually packaged in Tyvek plastic pouches and sold in corrugate cases containing 20 units each.
The recall was initiated because the product did not undergo correct sterilization procedures and may potentially be non-sterile. This defect poses a risk of infection if the bandages are used on open wounds or surgical sites.
The affected products were distributed nationwide in the United States and in Canada, Saudi Arabia, and the Netherlands. Consumers and healthcare facilities should stop using the affected bandages and contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 5,722
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)
- Model No. DYNJ05914
- Lots: 17GB3101
- 172B2025
- 17FB9612
- 17QB8614
Distribution
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