Teleflex Recalls Electrosurgical Suction Tubes Due to Sterility Concerns
Teleflex Medical is recalling 17,450 electrosurgical coagulation suction tubes because sterility cannot be guaranteed. The devices were distributed nationwide.
What this means for you
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 is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device used for tissue removal and bleeding control, which presents a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Teleflex Medical is recalling 17,450 units of the Weck Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet. The recall is being conducted because the sterility of the devices cannot be guaranteed. These medical devices are intended to remove tissue and control bleeding by using high-frequency electrical current.
The affected products are identified by Catalog Number 809600 and specific lot numbers: 01M1000201, 01A1100320, 01C1000012, 01C1000385, and 01E1000392. The recall covers a nationwide distribution of the product.
Healthcare facilities and distributors should stop using the affected devices and contact Teleflex Medical for further instructions. Patients who have had these devices used on them should consult their healthcare provider if they have concerns regarding the sterility of the equipment.
The recalled product
- Product
- Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770. Intended to remove tissue and control bleeding by use of high-frequency electrical current.
- Manufacturer
- Teleflex Medical
- Hazard
- 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 (6)
- Catalog Number: 809600
- Lot Numbers: 01M1000201
- 01A1100320
- 01C1000012
- 01C1000385
- 01E1000392.
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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