Recall Z-2940-2020— Medical Components, Inc dba MedComp

Name: FDA recall Z-2940-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-27

Class II · Terminated

Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2020-07-27, terminated 2021-04-30. It names one FDA 510(k) clearance: K994105. Product: Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024. Reason: Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer.

Recalling firm: Medical Components, Inc dba MedComp
Classification: Class II
Status: Terminated
Initiated: 2020-07-27
Terminated: 2021-04-30
Firm location: Harleysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K994105 — HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40Medical Components, Inc.·cleared 2001-10-03

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

Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024

Reason for recall

Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer

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