Recall Z-2492-2021— M.D.L. S.r.l.

Name: FDA recall Z-2492-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-05

Class II · Completed

Class II FDA medical device recall by M.D.L. S.r.l., initiated 2021-08-05. It names one FDA 510(k) clearance: K160316. Product: Soft Tissue Biopsy Needles. Reason: Sterility assurance may be compromised..

Recalling firm: M.D.L. S.r.l.
Classification: Class II
Status: Completed
Initiated: 2021-08-05
Firm location: Delebio, Italy

510(k) clearances named in this recall

1 on FDA's record

K160316 — SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L.·cleared 2016-10-27

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

Soft Tissue Biopsy Needles

Reason for recall

Sterility assurance may be compromised.

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