Recall Z-1082-2021— Cardinal Health 200, LLC

Name: FDA recall Z-1082-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-07

Class II · Terminated

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2021-01-07, terminated 2024-02-14. It names one FDA 510(k) clearance: K972615. Product: Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K. Reason: Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-01-07
Terminated: 2024-02-14
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K972615 — CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)Wembley Rubber Products (M) Sdn Bhd·cleared 1999-01-26

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

Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K

Reason for recall

Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.

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