FDA Medical Device Recalls (openFDA)
Remington Medical Inc.: Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.
- Recall number
- Z-1574-2011
- Recalling firm
- Remington Medical Inc.
- Product
- Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.
- Status
- Terminated
- Initiated
- 2011-02-07
- Posted
- 2011-03-07
- Terminated
- 2011-08-12
- Reason
- There is a potential for the needle hubs to break during use.
- Root cause
- Device Design
- Action
- Remington Medical consignees were notified via facsimile, email and certified mail starting 02/07/2011. Distributors are requested to communicate this recall to their customers. If a customer does not respond to the recall notice within one week of the recall notification, the customer will be contacted by telephone. If this is unsuccessful, the customer will be sent a second Recall Notice letter and Customer Inventory Reconcile Fax by certified mail by 28 February 2011. If there is no response at that point, RMI will consider the customer's inventory depleted. All return product for this recall will follow RMIs Returns Goods Authorization procedure (SOP7-200). All product returns and customer responses will be documented. Upon completion of the recall, the status will be updated and submitted for the FDA's recall closure process.
- Quantity
- 23022 units
- Distribution
- U.S. Nationwide
- Lot, serial or model codes
- Lot numbers: 090162 090289, 905416, 090684, 090758 and 090862.
- 510(k) numbers
- ["K040266"]
- 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
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