Medline nerve block trays contain recalled Mastisol liquid adhesive
Medline CCI Nerve Block Trays and CPNB kits are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
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 CCI Nerve Block Tray (DYNJRA2742) and Medline CPNB kit (DYNJRA2716) are 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.
Affected product is UDI-DI 10198459627330, lot 26AMA185, and UDI-DI 10198459567988, lot 25KBA971. Distribution was nationwide in the United States, with distribution outside the United States pending.
Facilities should identify affected stock using the kit numbers, UDI-DI codes and lot numbers above and follow the instructions issued by Medline.
The recalled product
- Product
- Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716
- Manufacturer
- Medline Industries, LP
- Affected units
- 49,654
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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