CLASS II Device recall · Reported 12 Aug 2020 · FDA Enforcement Report
Pleur-Evac Adult-Ped Wet, LF Intl Eng, product recalled
Teleflex Medical is recalling Pleur-Evac Adult-Ped Wet, LF Intl Eng, 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-2748-2020
- 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 Intl Eng, product code: A-8000I - 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: 74A1602932 74A1703007 74A1802909 74A1900358 74A2001172 74A2002639 74B1600856 74B1600857 74B1700269 74B1701278 74B1702684 74B1801734 74B1900875 74B1901993 74B1902825 74B2000066 74B2000361 74C1700392 74C1701906 74C1703150 74C1801547 74C1801548 74C2000213 74C2000214 74C2000473 74C2000754 74C2002285 74D1600915 74D1800630 74D1800632 74D1900143 74D1900144 74D1902087 74E1600936 74E1700397 74E1701189 74E1701196 74E1702207 74E1800301 74E1801286 74E1802464 74E1900510 74E1901525 74F1502198 74F1600345 74F1600460 74F1600461 74F1603155 74F1702091 74F1702491 74F1800692 74F1802178 74F1901722 74G1601816 74G1602512 74G1700142 74G1701822 74G1801551 74G1900712 74G1901738 74G1902569 74H1602162 74H1602618 74H1701206 74H1703208 74H1801031 74H1802122 74H1900242 74H1900251 74H1902213 74J1500448 74J1500865 74J1600969 74J1700548 74J1702261 74J1703038 74J1800939 74J1801384 74J1801385 74J1902581 74K1500387 74K1502281 74K1600247 74K1601780 74K1700695 74K1701305 74K1701886 74K1801271 74K1801272 74K1900069 74K1902094 74L1600158 74L1602510 74L1800465 74L1800953 74L1801262 74L1901155 74L1901156 74L1901427 74L1901428 74L1902305 74L1902306 74M1600558 74M1700229 74M1800724 74M1801532
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 85952This product is part of a recall event; the main page for the event is Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product recalled | Teleflex Medical | Sterility | Nationwide |
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