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Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x… recallZ-0771-2023 · Remington Medical, Inc. · initiated Dec 2, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Remington Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The stylet is longer than specified on the label

FDA root cause category: Under Investigation by firm

What the company is doing

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."

Recall details

Recall number
Z-0771-2023
Status
Terminated
Initiated by the company
Dec 2, 2022
Posted by the FDA
Dec 28, 2022
Recalling firm
Remington Medical, Inc.
Quantity
290 devices
Product code
KNW
FDA submissions
K191315
Distribution
NC, WV, CA, PA, AL, TX

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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