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FDA Medical Device Recalls (openFDA)

Remington Medical Inc.: 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.

Recall number
Z-0697-05
Recalling firm
Remington Medical Inc.
Product
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.
Status
Terminated
Initiated
2005-02-15
Posted
2005-04-08
Terminated
2005-05-17
Reason
The stylet hub detaches from the stylet needle.
Root cause
Other
Action
Consignees were notified by letter on 02/15/2005.
Quantity
1737 units
Distribution
Nationwide
Lot, serial or model codes
Lot number 043351 & 043272
510(k) numbers
["K982401"]
PMA numbers
not on file
Product code
KNW
Firm FEI
1000132370
Firm city
Alpharetta
Firm state
GA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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