FDA Medical Device Recalls (openFDA)
Maquet Inc.: Maquet HLM Tubing Pack; Bioline Coating
- Recall number
- Z-2401-2010
- Recalling firm
- Maquet Inc.
- Product
- Maquet HLM Tubing Pack; Bioline Coating
- Status
- Terminated
- Initiated
- 2010-07-13
- Posted
- 2010-09-12
- Terminated
- 2011-08-10
- Reason
- The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.
- Root cause
- Process control
- Action
- Recall notification letters were sent by Federal Express on July 13, 2010 to affected account and also an e-mail to the Maquet field representative who services the account.
- Quantity
- 5 units
- Distribution
- Distribution: Pennsylvania
- Lot, serial or model codes
- Product number BEQ-TOP 14801; lot numbers 70040244, 70046759.
- 510(k) numbers
- ["K053025"]
- PMA numbers
- not on file
- Product code
- DWE
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- 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