Recall Z-1125-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1125-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-07

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2022-12-07. It names one FDA 510(k) clearance: K962205. Product: Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063. Reason: The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2022-12-07
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K962205 — STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USEMedline Industries, Inc.·cleared 1996-11-26

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

Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063

Reason for recall

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

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