Z-1582-2016Class II

Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical

Name: Z-1582-2016 Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical
Creator: Teleflex Medical
Published: 2016-03-30
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2016-03-30 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of 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... on 2016-03-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1582-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-30
Posted: 2016-04-28
Terminated: 2025-01-30
Recalling firm: Teleflex Medical
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
Product code: CAC Apparatus, Autotransfusion
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Teleflex sent an Urgent Medical Device Recall Notification dated March 30, 2016 to customers and distributors. The letter identified the affected product, problem and actions to be taken. The letter requested that they discontinue use and quarantine any products. The letter instructed customers to complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected].. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 12,124 ea.
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1582-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1582-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-27

Product code CAC

K140205Class IIPleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion SystemTeleflexmedical, Inc. / cleared 2014-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)