Recall Z-2649-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-2649-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-23

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-05-23. It names one FDA 510(k) clearance: K890897. Product: Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.. Reason: The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2023-05-23
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 Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.

Reason for recall

The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.

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