Remington MEDICAL…

Date

Jan. 4, 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

Terminated

Filed by

Remington Medical, Inc.

Product

Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)

Reason

The stylet is longer than specified on the label

Distribution pattern

NC, WV, CA, PA, AL, TX

Quantity

290 devices

Codes and lots

UDI/DI 00813079020936, Lot Number 2224920, exp. 2025-09/06

Recall started

Dec. 2, 2022

Device type

Instrument, Biopsy

Root cause (FDA)

Under Investigation by firm

What the company told customers

The firm issued an URGENT: RECALL NOTIFICATION LETTER to its consignees on 12/02/2022 by email. The notice requested the following: "Actions to be Taken: The following steps are to be taken by all impacted customers: 1. Please be aware that this issue may be present in your company s inventory (refer to the impacted lot number listed below). Please communicate the possibility of this issue to all parties in your facility who may be impacted so that they are aware of the potential risks associated with this product and so replacement products may be obtained, if necessary. 2. Complete the enclosed Notice Reply Form and fax it to the attention of RMI s QA Recall Coordinator, at 770-888-8524 or scan the completed form and e-mail to quality@remmed.com. The form lists the catalog number(s) and lot number(s) of impacted product our records indicate your facility has received. 3. Enter the quantity of the affected product you wish to be replaced in the Quantity to be Replaced column. Enter a 0 if you do not require any replacements for this lot. 4. Dispose of any affected inventory per your facility s policies and procedures." "NOTE: If you are a distributor who has physically shipped this product to another location, such as a customer or end user, please provide this letter to the recipient of the product so that the requested actions above may be completed."

Recall number

Z-0771-2023

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

Source: FDA · Medical device enforcement report, recall number Z-0771-2023. The agency record governs; check it and the company before acting.