FDA Device recall Z-1582-2016
Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical by Teleflex Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1582-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-30 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Teleflex Medical |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | Product Code A-1500-08LF - Lot/Batch Numbers: 74J1501715, 74K1501006, 74L1500163; Product Code A-430-08LF - Lot/Batch N…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1582-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.