CLASS II Device recall · Reported 9 Sep 2020 · FDA Enforcement Report
Pleur-evac Thoracic Catheters recalled by Teleflex Medical
Teleflex Medical is recalling Pleur-evac Thoracic Catheters, distributed in 23 states. The recall was initiated on 7 Aug 2020 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-2922-2020
- FDA event ID
- 86200
- Recalling firm
- Teleflex Medical, Morrisville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Aug 2020
- FDA classified
- 28 Aug 2020
- Reported
- 9 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 Aug 2020 | Recall initiated by company | |
| 28 Aug 2020 | Classified by FDA | +21 days |
| 9 Sep 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential sterility issue
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 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.
Where it was distributed
US Distribution of states to: 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 WI
ArkansasArizonaCaliforniaColoradoFloridaGeorgiaIowaIllinoisLouisianaMichiganMinnesotaMississippiNorth CarolinaNew HampshireNevadaNew YorkPennsylvaniaSouth DakotaTennesseeTexas
Questions about this recall
Why was it recalled?
Potential sterility issue
Which lots are affected?
74K1900074 74K1901335 74L1901435 74M1900809
Where was it sold?
US Distribution of states to: 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 WI
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.
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|---|---|---|---|---|---|
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| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
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