Teleflex Recalls Electrosurgical Coagulation Suction Tubes Due to Sterility Concerns
Teleflex Medical is recalling 17,450 electrosurgical coagulation suction tubes because sterility cannot be guaranteed. The devices are distributed nationwide.
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: The recall involves a medical device where sterility cannot be guaranteed, posing a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex Medical is recalling 17,450 units of the Weck Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet. The recall is being conducted because the sterility of the devices cannot be guaranteed. The affected products are identified by Catalog Number 809610 and Lot Number 01A1100610.
These medical devices are intended to remove tissue and control bleeding by using high-frequency electrical current. The recall covers a nationwide distribution of the product.
Healthcare facilities and consumers should stop using the affected devices and contact Teleflex Medical for further instructions on how to proceed.
The recalled product
- Product
- Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and control bleeding by use of high-frequency electrical current.
- Manufacturer
- Teleflex Medical
- Affected units
- 17,450
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 (2)
- Catalog Number: 809610
- Lot Number: 01A1100610.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teleflex Medical 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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