Fabric bandages recalled over open package seals affecting product sterility
Medline is recalling 182,526 CURAD Germ-Shield Touch-Free Fabric Bandages because packaging may exhibit open seals that could compromise the sterility of the product.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: the firm states open package seals may compromise sterility of a product applied to wounds, and no injuries are reported.
Plain-English summary
CURAD Germ-Shield Touch-Free Fabric Bandages, sterile, 0.75" x 3", 30 per box, Medline item number CUR1930F, are being recalled by Medline Industries, LP.
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
The recall covers 182,526 units across all lots, carrying UDI/DI 10888277702752 for each, 00888277702755 for the box and 20888277702759 for the case. Distribution covered the United States, Guam, Canada and the United Arab Emirates. The FDA has classified the action as Class II.
A bandage whose sterile barrier is open may no longer be sterile when applied. The enforcement record reports no injuries. Customers should follow Medline's instructions.
The recalled product
- Product
- CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Wound dressing
- Affected units
- 182,526
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)
- UDI/DI 10888277702752 (each)
- 00888277702755 (box)
- 20888277702759 (case)
- ALL LOTS
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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