Z-0771-2023Class II

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

Name: Z-0771-2023 Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
Creator: Remington Medical, Inc.
Published: 2022-12-02
License: https://open.fda.gov/license/

Remington Medical / initiated 2022-12-02 / Terminated / root cause: labeling and UDI

FDA source

Remington Medical, Inc. began a recall of Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1) on 2022-12-02. FDA classified it as Class II and gives the reason as "The stylet is longer than specified on the label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0771-2023
Classification: Class II
Status: Terminated
Initiated: 2022-12-02
Posted: 2022-12-28
Terminated: 2026-03-16
Recalling firm: Remington Medical
Product: Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
Product code: KNW Instrument, Biopsy
Reason for recall: The stylet is longer than specified on the label
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
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."
Quantity in commerce: 290 devices
Distribution: NC, WV, CA, PA, AL, TX
Product codes and lots: UDI/DI 00813079020936, Lot Number 2224920, exp. 2025-09/06

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0771-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0771-2023	Class II	Terminated	Voluntary: Firm initiated	2023-01-04	2022-12-28

Product code KNW

K191315Class IIRemington Medical, Inc. Automatic Cutting Needle (NAC)Remington Medical, Inc. / cleared 2019-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)