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Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20… recallZ-0697-05 · Remington Medical Inc. · initiated Feb 15, 2005

Terminated All recalls posted in April 2005

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 hub detaches from the stylet needle.

FDA root cause category: Other

What the company is doing

Consignees were notified by letter on 02/15/2005.

Recall details

Recall number
Z-0697-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 15, 2005
Posted by the FDA
Apr 8, 2005
Recalling firm
Remington Medical Inc.
Quantity
1737 units
Product code
KNW
FDA submissions
K982401
Distribution
Nationwide

Product description

Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005.

Code information (models, lots, serial numbers)

Lot number 043351 & 043272

Other devices under the same FDA submission

1 device cleared under K982401 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page