Teleflex Pleur-evac Thoracic Catheters Recalled for Potential Sterility Issue
Teleflex Medical Inc is recalling Pleur-evac Thoracic Catheters due to a potential sterility issue. The recall affects 700 units distributed across 25 US states.
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 potential sterility issue in a medical device used in surgical procedures, which poses a risk of harm even without reported injuries.
Plain-English summary
Teleflex Medical Inc is recalling 700 units of Pleur-evac Thoracic Catheters, Catalog No. DTRC-20S. The recall was initiated due to a potential sterility issue with the devices. These catheters are indicated for use in surgical procedures requiring attachment to a Chest Drainage device and are intended for use for less than 30 days.
The affected units were distributed to 25 US states, including AR, AZ, CA, CO, FL, GA, IA, IL, IN, LA, MI, MN, MS, NC, NH, NV, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, and WI. The specific lot codes associated with this recall are 74K1900074, 74K1901335, 74L1901435, and 74M1900809.
Healthcare providers and facilities should check their inventory for these specific catalog and lot numbers. If the devices are found, they should be removed from use and returned to Teleflex Medical Inc or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.
- Manufacturer
- TELEFLEX MEDICAL INC
- Hazard
- Affected units
- 700
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 (1)
- 74K1900074 74K1901335 74L1901435 74M1900809
Distribution
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