Z-1575-2011

Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10), Remington...

Name: Z-1575-2011 Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10), Remington...
Creator: Remington Medical Inc.
Published: 2011-02-07
License: https://open.fda.gov/license/

Remington Medical / initiated 2011-02-07 / Terminated / root cause: design

FDA source

Remington Medical Inc. began a recall of Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc on 2011-02-07. The reason FDA records is "There is a potential for the needle hubs to break during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1575-2011
Status: Terminated
Initiated: 2011-02-07
Posted: 2011-03-07
Terminated: 2011-08-12
Recalling firm: Remington Medical
Product: Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc.
Product code: KNW Instrument, Biopsy
Reason for recall: There is a potential for the needle hubs to break during use.
Root cause tag: design
FDA 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 in commerce: 4867 units
Distribution: U.S. Nationwide
Product codes and lots: Lot numbers: 083383 and 090582

Product code KNW

K040266Class IICore Needle BiopsyRemington Medical, Inc. / cleared 2004-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)