Pleur-evac Chest Drainage System — Class II medical device recall Z-1582-2016
Terminated recall by Teleflex Medical, reported 2016-05-04, distributed nationwide. The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and ex
| Recall number | Z-1582-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2016-03-30 |
| Classified | 2016-04-27 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2025-01-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CL, DE, DO |
| Quantity | 12,124 units |
| Reason classes | labeling |
| Lot numbers | 74J1501715, 74J1501725, 74K1500364, 74K1500365, 74K1500367, 74K1500369, 74K1500372, 74K1500376, 74K1500379, 74K1500381, 74K1500382, 74K1500383, 74K1500385, 74K1500391, 74K1500907, 74K1500908, 74K1500909, 74K1500910, 74K1500913, 74K1500915, 74K1500922, 74K1500975, 74K1501006, 74K1501007, 74K1501008, 74K1501010, 74K1501014, 74K1501021, 74K1501025, 74K1501026, 74K1501028, 74K1501032, 74K1501039, 74K1501041, 74K1501043, 74K1502263, 74K1502264, 74K1502267, 74K1502274, 74K1502277 and 13 more |
| Model numbers | A-6000-08LF |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1582-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.