FDA Recall Terminated

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

Recall: Z-0771-2023 · Initiated December 2, 2022

Recall

Recall Number
Z-0771-2023
Event Number
91275
Firm
Remington Medical, Inc.
FEI Number
1000132370
Product Code
KNW
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
December 2, 2022
Posted
December 28, 2022
Terminated
March 16, 2026
Address
6830 Meadowridge Ct, Alpharetta, GA, 30005-2202

Description

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

Reason

The stylet is longer than specified on the label

Action

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 [email protected]. 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."

Distribution

NC, WV, CA, PA, AL, TX

Quantity

290 devices