Medline Industries, Lp: Cardiac Catheterization Kit
Recall Summary Medline Convenience cardiac catheterization kits containing Swan-Ganz catheters are being recalled because the catheters have a defective blue hub on the proximal injectate lumen that can leak or break during use. This defect can cause leakage, lumen damage, breakage, infection, medication loss, and blood loss. The affected kits (model DYNJ68530A) were distributed nationwide.
- Recalling firm
- Medline Industries, LP
- Product
- Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
- 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/aef80964-5d42-47d6-9c8a-4f179cf900f9