Recall Z-0487-2024— Remington Medical, Inc.

Name: FDA recall Z-0487-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-03

Class II · Ongoing

Class II FDA medical device recall by Remington Medical, Inc., initiated 2023-11-03. It names one FDA 510(k) clearance: K990428. Product: Remington MEDICAL Drainage Bag, REF 600-D;. Reason: There is an error with the "Use by Date" and "Date of Manufacturer" on the box label..

Recalling firm: Remington Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-11-03
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K990428 — DRAINAGE BAGRemington Medical, Inc.·cleared 1999-08-12

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

Remington MEDICAL Drainage Bag, REF 600-D;

Reason for recall

There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.

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