Medline Industries, Lp: Cardiac Catheterization Kit
Recall Summary Medline Convenience cardiac catheterization kits containing Swan-Ganz catheters are being recalled because the blue connector hub on the catheters can leak, break, or fail, potentially causing medication loss, blood loss, or infection. The affected kit is model DYNJ68530B (RIGHT HEART CATH PACK CTX), distributed nationwide. This is a Class II recall affecting medical facilities in multiple states.
- Recalling firm
- Medline Industries, LP
- Product
- Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-28
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/0077ff1a-9d59-416f-8f87-8a5707258b84