Recall Z-1407-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1407-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-02

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-03-02. It names one FDA 510(k) clearance: K890897. Product: Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.. Reason: The CirClamp subassembly found in the kit was the incorrect size..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2023-03-02
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K890897 — CENTURION CIRCLAMPTri-State Hospital Supply Corp.·cleared 1989-03-28

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

Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.

Reason for recall

The CirClamp subassembly found in the kit was the incorrect size.

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