Teleflex Recalls PLEUR-EVAC Thoracic Catheters Due to Sterility Concerns
Teleflex is recalling 520 PLEUR-EVAC Thoracic Catheters because the company cannot guarantee the devices are sterile.
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 is classified as FDA Class II, and the hazard involves a lack of assurance of sterility for a medical device, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Teleflex Medical Inc is recalling 520 units of PLEUR-EVAC Thoracic Catheters (Catalog No. DRAC-32S, Lot No. 73J2000276). The recall was initiated due to a lack of assurance of sterility for these single-use medical devices.
The affected catheters are sterile, non-pyrogenic devices used to drain fluid from the mediastinum and/or pleural space. They are composed of phthalate-free PVC and are available in straight, right angle, and trocar configurations. The specific units involved in this recall are identified by Manufacturing Lot/Serial No. 73J2000276.
These devices were distributed nationwide in the United States, specifically in the states of Illinois, Pennsylvania, Florida, New Jersey, Connecticut, New York, and Tennessee. Healthcare providers and facilities that have received these specific lot numbers should stop using the devices and contact Teleflex for further instructions.
The recalled product
- Product
- PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in…
- Manufacturer
- TELEFLEX MEDICAL INC
- Category
- Medical Device — Catheters
- Affected units
- 520
Distribution
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