Recall Z-1149-2019— Medical Components, Inc dba MedComp

Name: FDA recall Z-1149-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-13

Class II · Terminated

Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2019-03-13, terminated 2024-03-05. It names one FDA 510(k) clearance: K893439. Product: 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422. Reason: Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer..

Recalling firm: Medical Components, Inc dba MedComp
Classification: Class II
Status: Terminated
Initiated: 2019-03-13
Terminated: 2024-03-05
Firm location: Harleysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K893439 — HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40CMedical Components, Inc.·cleared 1989-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422

Reason for recall

Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

Data sourced from openFDA. This site is unofficial and independent of the FDA.