Adhesive bandages recalled over open package seals that may compromise sterility
Medline is recalling 1,566,500 Fur Friends Plastic Sterile Adhesive 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
Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline item number NON256133QS, 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 enforcement record gives that statement as the reason for this recall.
The recall covers 1,566,500 units across all lots, carrying UDI/DI 30888277715947 for each, 10888277715943 for the box and 20888277715940 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
- Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Category
- Medical Device — Wound dressing
- Affected units
- 18
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 (3)
- Item Number: 15-0028/08
- UDI-DI: 04026575175222
- Lot Number: 2535004
Distribution
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