PLEUR-EVAC recallZ-1298-2021 · Teleflex Medical Inc · initiated Feb 12, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Teleflex Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Teleflex is recalling this product due to a lack of assurance of sterility.
FDA root cause category: Under Investigation by firm
What the company is doing
The affected customer is instructed to take the following actions: 1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products.
Recall details
- Recall number
- Z-1298-2021
- Status
- Terminated
- Initiated by the company
- Feb 12, 2021
- Recalling firm
- Teleflex Medical Inc
- Quantity
- 520 units (US only)
- Product code
- GBX
- Distribution
- US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
Product description
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 straight, right angle, and trocar configurations in a variety of sizes. The catheter is soft enough to prevent tissue laceration during insertion and tissue pressure necrosis due to the catheter being left in place for a period of time. The catheter is also rigid enough to facilitate insertion of the tube and to avoid obstruction by external compression or kinking.
Code information (models, lots, serial numbers)
Catalog No.: DRAC-32S. Manufacturing Lot/Serial No.: 73J2000276. GTIN: 14026704631404 (EACH)/ GTIN: 34026704631408 (CASE)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PLEUR-EVAC IPN028459Teleflex Incorporated · CATHETER, IRRIGATION1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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