Teleflex Recalls Simplastic Suprapubic Puncture Instruments for Missing Latex Warning
Teleflex Medical Europe Ltd is recalling Simplastic Suprapubic Puncture Instruments because the packaging lacks a required warning that the products contain natural rubber latex.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, and the hazard is a labeling omission regarding a known allergen, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Teleflex Medical Europe Ltd is recalling 4,220 units of Simplastic Suprapubic Puncture Instruments distributed nationwide in the United States. The recall involves specific product codes and batch numbers, including 650704100, 650704120, and 650704160.
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 the product packaging. This omission prevents healthcare providers and patients from being aware of the potential for allergic reactions.
Healthcare facilities and consumers who have these products should stop using them and contact Teleflex Medical Europe Ltd for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic…
- Manufacturer
- Teleflex Medical Europe Ltd
- Affected units
- 4,220
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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Similar recalls
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