Recall Z-2217-2019— Medical Components, Inc dba MedComp

Name: FDA recall Z-2217-2019
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 x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter. 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 x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter

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.