Pleur-Evac Adult-Ped Wet, LF Intl Eng
Medical device recall Z-2748-2020. Published in FDA’s Enforcement Report on Aug 12, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 12, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 204644 each (OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential for sterile packaging to be compromised¿
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
204644 each (OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers: 74A1602932 74A1703007 74A1802909 74A1900358 74A2001172 74A2002639 74B1600856 74B1600857 74B1700269 74B1701278 74B1702684 74B1801734 74B1900875 74B1901993 74B1902825 74B2000066 74B2000361 74C1700392 74C1701906 74C1703150…
Every code shown here, 1,178 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- Florida
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 30, 2020.
- FDA classified it on Aug 3, 2020.
- FDA’s Enforcement Report published it on Aug 12, 2020.
- FDA terminated it on Jul 2, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- TELEFLEX MEDICAL INC, of Morrisville, NC.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.