Teleflex Baker Jejunostomy Tubes Recalled for Missing Latex Warning
Teleflex Medical Europe Ltd is recalling 200 Baker Jejunostomy Tubes because the packaging lacks a required warning that the product contains natural rubber latex.
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: This is a Class II recall involving a labeling error (missing latex warning) which poses a risk of allergic reaction but is not associated with reported serious injury or death in the source text.
Plain-English summary
Teleflex Medical Europe Ltd is recalling 200 units of Baker Jejunostomy Tubes. The recall involves product codes 655300160 (equivalent 655316) and 655500200 (equivalent 655520). The specific batch numbers affected are 13EG28 and 13HG23 for the first product code, and 13EG28 for the second. The products were distributed nationwide in the United States.
The reason for the recall is that the products contain latex, but the required statement "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions" is not included on any level of product packaging. This omission prevents patients and healthcare providers from being aware of the latex content, which may cause allergic reactions in sensitive individuals.
This recall is classified as Class II by the FDA. Consumers and healthcare facilities should check their inventory for these specific product codes and batch numbers. If found, the products should be removed from use and returned to Teleflex Medical Europe Ltd or the distributor.
The recalled product
- Product
- Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
- Manufacturer
- Teleflex Medical Europe Ltd
- Affected units
- 200
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Teleflex Medical Europe Ltd 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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