FDA Medical Device Recalls (openFDA)
Remington Medical Inc.: Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy Needle
- Recall number
- Z-1935-2009
- Recalling firm
- Remington Medical Inc.
- Product
- Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy Needle
- Status
- Terminated
- Initiated
- 2009-06-19
- Posted
- 2009-09-20
- Terminated
- 2009-10-23
- Reason
- Two unsealed pouches were identified after product release, compromising product sterility.
- Root cause
- Process control
- Action
- Initial notification to consignees was issued via telephone on June 19, 2009 and by certified mail on June 30, 2009. They were instructed to examine their inventory and quarantine product subject to the recall. If the product was further distributed, they were advised to identify their customers and notify them at once of the recall via the recall letter. A Return Authorization number was provided. Forty of 50 units in distribution were returned from the two customers.
- Quantity
- 50 units
- Distribution
- US - CA and WI.
- Lot, serial or model codes
- Lot number 091386.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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