CLASS II Device recall · Reported 31 Mar 2021 · FDA Enforcement Report
Pleur-evac Thoracic Catheters (Catheter, Irrigation) recalled
Teleflex Medical is recalling Pleur-evac Thoracic Catheters (Catheter, Irrigation), distributed nationwide in the US. The recall was initiated on 12 Feb 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1298-2021
- FDA event ID
- 87346
- Recalling firm
- Teleflex Medical, Morrisville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Feb 2021
- FDA classified
- 24 Mar 2021
- Reported
- 31 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 12 Feb 2021 | Recall initiated by company | |
| 24 Mar 2021 | Classified by FDA | +40 days |
| 31 Mar 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Teleflex is recalling this product due to a lack of assurance of sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
Nationwide ConnecticutFloridaIllinoisNew JerseyNew YorkPennsylvaniaTennessee
Questions about this recall
Why was it recalled?
Teleflex is recalling this product due to a lack of assurance of sterility.
Which lots are affected?
Catalog No.: DRAC-32S. Manufacturing Lot/Serial No.: 73J2000276. GTIN: 14026704631404 (EACH)/ GTIN: 34026704631408 (CASE)
Where was it sold?
US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teleflex Medical
All 235| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS II | Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile recalled | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |