Reported May 4, 2016 · Terminated
Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product…
Teleflex Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teleflex Medical · 2917 Weck Dr · Research Triangle Park, NC · 27709-0186
Is this the product you have?
- Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical
- Product UsagePleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use
- Lot codes and dates
15 of 15 products
Products covered by this recall Model / number Product as published A-1500-08LFLot/Batch Numbers: 74J1501715, 74K1501006, 74L1500163 A-430-08LFLot/Batch Numbers: 74K1500975, 74K1502313, 74L1500164, 74L1500165 A-6000-08LFLot/Batch Numbers: 74K1500364, 74K1500365, 74K1500367, 74K1500907, 74K1500908, 74K1501007, 74K1501008, 74K1501010, 74K1501014, 74K1502274, 74L1502302, 74L1502304 A-6002-08LFLot/Batch Numbers: 74K1500391, 74K1500909, 74K1500910, 74K1503003, 74L1500179 A-6020-08LFLot/Batch Number: 74L1500180 A-7000-08LFLot/Batch Numbers: 74K1500372, 74K1500913, 74K1501021, 74K1502277 A-8000-08LFLot/Batch Numbers: 74K1500369, 74K1500915, 74K1501025, 74K1501026, 74K1501028, 74K1502263, 74K1502264, 74L1500190 A-8002-08LFLot/Batch Numbers: 74K1500376, 74K1501032 S-0500Lot/Batch Number: 74K1500379 S-100-08LFLot/Batch Number: 74K1501039 S-1100-08LFLot/Batch Numbers: 74K1500381, 74K1501041, 74K1502267, 74L1500208, 74L1500209, 74L1500210 S-1102-08LFLot/Batch Numbers: 74K1500382, 74K1500383 S-1103-08LFLot/Batch Number: 74K1500922 S-1150-08LFLot/Batch Number: 74J1501725 S-1200-08LFLot/Batch Numbers: 74K1500385, 74K1501043 - Amount recalled
- 12,124 ea.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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