FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
- Recall number
- Z-2609-2026
- Recalling firm
- Medline Industries, LP
- Product
- Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
- Status
- Open, Classified
- Initiated
- 2026-05-28
- Posted
- 2026-06-26
- Terminated
- not on file
- Reason
- Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
- Root cause
- Process change control
- Action
- On May 28, 2026, the firm notified customers via letters titled "URGENT MEDICAL DEVICE CORRECTION." Customers were referred to BD's recall notice, which provides advice for users and instructions to mitigate hub breakage issues. Product return is not required. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Quantity
- 9,272 kits
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
- Lot, serial or model codes
- DYNJ905855 UDI-DI 10193489546606 Lots 21ABU297 21BBB235 21DBV520 21FBG162 21GBC672 21GBI192 21IBT387 21VBB580 22DBK812 22FBR093 22FBS035 22HBI628 22IBV291 22JBX729 22NBE430 23ABD954 23BBI465 23CBO951 23CBX474 23GBF721 DYNJ905857 UDI-DI 10193489545678 Lots 21ABG510 21GBK940 DYNJ905936B UDI-DI 10193489422818 Lots 21BBF766 21DBP452 21FBF248 21LBJ459 22ABV319 22DBS751 22FBU868
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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