Recall Z-2444-2026— Medline Industries, LP
Class II · Ongoing
Class II FDA medical device recall by Medline Industries, LP, initiated 2026-04-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK DYNJ35761D PACER / CATH LAB PACK-LF DYNJ0972604A PACER CDS CDS983686I PACER PACK DYNJ52059D PK, EP LAB PACEMAKER DYNJ43663A VENOUS ACCESS PACK DYNJ45640B. Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application..
- Recalling firm
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-04-27
- Firm location
- Northfield, IL, United States
Product description
Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK DYNJ35761D PACER / CATH LAB PACK-LF DYNJ0972604A PACER CDS CDS983686I PACER PACK DYNJ52059D PK, EP LAB PACEMAKER DYNJ43663A VENOUS ACCESS PACK DYNJ45640B
Reason for recall
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Data sourced from openFDA. This site is unofficial and independent of the FDA.