FDA DeviceClass IINotable
FDA Recall: MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2)
Description
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Hazard
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Remedy
4801 units
Related Recalls
2026-06-24 · FDA_DEVICE
FDA Recall: Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716
Medline Industries, LP
2026-06-24 · FDA_DEVICE
FDA Recall: MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G
Medline Industries, LP
2026-06-24 · FDA_DEVICE
FDA Recall: BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A
Medline Industries, LP
2026-06-24 · FDA_DEVICE
FDA Recall: Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG CHG K
Medline Industries, LP