FDA Recall
Open, Classified
MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G
Recall: Z-2417-2026
·
Initiated April 27, 2026
Recall
- Recall Number
- Z-2417-2026
- Event Number
- 98951
- FEI Number
- 1417592
- Product Code
- OES
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- April 27, 2026
- Posted
- June 12, 2026
- Address
- 3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753
Description
MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G
Reason
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Action
Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.
Distribution
US Nationwide distribution. OUS distribution pending.
Quantity
49,654 kits total