CLASS II Device recall · Reported 4 May 2016 · FDA Enforcement Report
Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control recalled
Teleflex Medical is recalling Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, distributed nationwide in the US. The recall was initiated on 30 Mar 2016 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-1582-2016
- FDA event ID
- 73676
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Mar 2016
- FDA classified
- 27 Apr 2016
- Reported
- 4 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 30 Mar 2016 | Recall initiated by company | |
| 27 Apr 2016 | Classified by FDA | +28 days |
| 4 May 2016 | 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
The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.
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 Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use
Where it was distributed
Worldwide Distribution - US Nationwide in the states of: AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, LA, MD, MA, MI, MS, MO. MT, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WV, Puerto Rico, Belgium, Canada, Chile, Dominican Republic & Germany
Nationwide ArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisIndianaKansasLouisianaMassachusettsMarylandMichiganMissouriMississippiMontanaNorth CarolinaNew Hampshire
Questions about this recall
Is Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control recalled?
Yes. Teleflex Medical recalled Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control on 30 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1582-2016.
Why was it recalled?
The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.
Which lots are affected?
Product Code A-1500-08LF - Lot/Batch Numbers: 74J1501715, 74K1501006, 74L1500163; Product Code A-430-08LF - Lot/Batch Numbers: 74K1500975, 74K1502313, 74L1500164, 74L1500165; Product Code A-6000-08LF - Lot/Batch Numbers: 74K1500364, 74K1500365, 74K1500367, 74K1500907, 74K1500908, 74K1501007, 74K1501008, 74K1501010, 74K1501014, 74K1502274, 74L1502302, 74L1502304; Product Code A-6002-08LF - Lot/Batch Numbers: 74K1500391, 74K1500909, 74K1500910, 74K1503003, 74L1500179; Product Code A-6020-08LF - Lot/Batch Number: 74L1500180; Product Code A-7000-08LF - Lot/Batch Numbers: 74K1500372, 74K1500913, 74K1501021, 74K1502277; Product Code A-8000-08LF - Lot/Batch Numbers: 74K1500369, 74K1500915, 74K1501025, 74K1501026, 74K1501028, 74K1502263, 74K1502264, 74L1500190; Product Code A-8002-08LF - Lot/Batch Numbers: 74K1500376, 74K1501032; Product Code S-0500 - Lot/Batch Number: 74K1500379; Product Code S-100-08LF - Lot/Batch Number: 74K1501039; Product Code S-1100-08LF - Lot/Batch Numbers: 74K1500381, 74K1501041, 74K1502267, 74L1500208, 74L1500209, 74L1500210; Product Code S-1102-08LF - Lot/Batch Numbers: 74K1500382, 74K1500383; Product Code S-1103-08LF - Lot/Batch Number: 74K1500922; Product Code S-1150-08LF - Lot/Batch Number: 74J1501725; Product Code S-1200-08LF - Lot/Batch Numbers: 74K1500385, 74K1501043
Where was it sold?
Worldwide Distribution - US Nationwide in the states of: AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, LA, MD, MA, MI, MS, MO. MT, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WV, Puerto Rico, Belgium, Canada, Chile, Dominican Republic & Germany
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 21 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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