FDA Medical Device Recalls (openFDA)
B Braun Medical Inc: CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
- Recall number
- Z-2155-2017
- Recalling firm
- B Braun Medical Inc
- Product
- CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
- Status
- Terminated
- Initiated
- 2017-04-10
- Posted
- not on file
- Terminated
- 2018-02-02
- Reason
- B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.
- Root cause
- Nonconforming Material/Component
- Action
- B. Braun mailed an Urgent Medical Device Recall Notice to affected customers to inform them of the issue. Customers were asked to determine their current inventory and to not destroy any of the product; however, product should be discontinued immediately and quarantined and return the acknowledgement form for product return.
- Quantity
- 417,600 units
- Distribution
- United States Nationwide distribution
- Lot, serial or model codes
- Lot # 1240156001, 1240156002, 1240156003, 1240156004, 1370249001, 1370251101, 1370257101, 1370259201, 1370268401, 1370270401, 1370273801, 1470311101, and 1570315301
- 510(k) numbers
- ["K112636"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3003218564
- Firm city
- Breinigsville
- Firm state
- PA
- 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