CLASS II Device recall · Reported 12 Aug 2020 · FDA Enforcement Report
Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product recalled
Teleflex Medical is recalling Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, distributed nationwide in the US. The recall was initiated on 30 Jun 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-2749-2020
- FDA event ID
- 85952
- Recalling firm
- Teleflex Medical, Morrisville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2020
- FDA classified
- 3 Aug 2020
- Reported
- 12 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 30 Jun 2020 | Recall initiated by company | |
| 3 Aug 2020 | Classified by FDA | +34 days |
| 12 Aug 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for sterile packaging to be compromised¿
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 Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and maintain normal intra-thoracic pressure gradients. To facilitate complete lung re-expansion to restore normal breathing dynamics.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of FL, PR and the countries of AL, BR, CR, EC, ES, GB, GR, HK, HN, ID, IT, MX, PA, PE, PH, PK, PR, SG, SV, VE.
Questions about this recall
Why was it recalled?
Potential for sterile packaging to be compromised¿
Which lots are affected?
Lot Numbers: 74A1801125 74A1902739 74A2000267 74A2000268 74A2000745 74A2000746 74A2000747 74A2001170 74A2001171 74A2001934 74A2001935 74A2001936 74B1800758 74B2000067 74B2000068 74B2000363 74B2000364 74C1800921 74C1801541 74C1900767 74C1902202 74C2000217 74C2000474 74C2001737 74C2001769 74C2001770 74D1700243 74D1801534 74D1802402 74D1902703 74E1701799 74E1900882 74E1901526 74F1500554 74F1500555 74F1500731 74F1700647 74F1700648 74F1702092 74F1900390 74F1900391 74F1901723 74G1600770 74G1601461 74G1801221 74G1900713 74H1502743 74H1502805 74H1800551 74H1802708 74H1802709 74H1900252 74H1901558 74J1500223 74J1500904 74J1502363 74J1800509 74J1802225 74J1802226 74J1900253 74J1901144 74J1901636 74K1500375 74K1500917 74K1501031 74K1502282 74L1500196 74L1500197 74L1500198 74L1801592
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of FL, PR and the countries of AL, BR, CR, EC, ES, GB, GR, HK, HN, ID, IT, MX, PA, PE, PH, PK, PR, SG, SV, VE.
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.
Other products in this recall event
1 other product · FDA event 85952| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pleur-Evac Adult-Ped Wet, LF Intl Eng, product recalled | Teleflex Medical | Sterility | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
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| 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 |
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