Remington MEDICAL Drainage Bag…

Date

Dec. 13, 2023

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Remington Medical, Inc.

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.

Distribution pattern

US: PA and FL

Quantity

3080 devices

Codes and lots

UDI/DI 20813079020008, Lot Number 2325111

Recall started

Nov. 3, 2023

Device type

Bag, Bile Collecting

Root cause (FDA)

Labeling mix-ups

What the company told customers

Remington Medical issued an URGENT: RECALL NOTIFICATION LETTER to its consignees on 11/03/2023 via email. The notice explained the issue, the potential risk, and requested the notice be communicated to all parties to whom it was distributed. If allowed by the consignee's internal procedures, remove the pouches from the box, as the pouch label correctly identifies the actual Date of Manufacture date and Use By date. The firm will replace the affected devices.

Recall number

Z-0487-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0487-2024. The agency record governs; check it and the company before acting.