Medline Industries, LP: Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ90
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
- Recall initiated
- 2026-05-28
- Code info
- 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
- Product quantity
- 9,272 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 99209
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