FDA Medical Device Recalls (openFDA)
Teleflex Medical: 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
- Recall number
- Z-1582-2016
- 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
- Status
- Terminated
- Initiated
- 2016-03-30
- Posted
- not on file
- Terminated
- 2025-01-30
- 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.
- 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 recalls@teleflex.com.. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
- Quantity
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K140205"]
- PMA numbers
- not on file
- Product code
- CAC
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28