Medline IV start kits with HubGuard contain recalled Mastisol adhesive
The Medline IV Start Kit with HubGuard is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall where the described consequence is that a component becomes unusable rather than any patient hazard, which fits the Moderate band.
Plain-English summary
The Medline IV Start Kit with HubGuard, SKU DYNDV2662, UDI-DI 10653160378518, lot 26CBC731, is being recalled. The action covers 49,654 kits in total across the connected Medline Mastisol recalls.
The stated reason is that the kits contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive. According to the notice, the butyrate tubing may crack during actuation and render the product unusable for application. The FDA classified the action as Class II. The source does not describe any patient hazard beyond the product being unusable.
Distribution was nationwide in the United States, with distribution outside the United States pending.
Facilities should identify affected stock using the kit number, UDI-DI and lot number above and follow the instructions issued by Medline.
The recalled product
- Product
- Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — IV start kit
- Affected units
- 49,654
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 (1)
- UDI-DI 10653160378518 Lot 26CBC731
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 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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