Z-1063-2011

Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model...

Name: Z-1063-2011 Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model...
Creator: Inrad, Inc
Published: 2010-12-20
License: https://open.fda.gov/license/

RLS Interventional Inc. dba Inrad / initiated 2010-12-20 / Terminated / root cause: manufacturing process

FDA source

Inrad, Inc began a recall of Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad, Inc. Kentwood, MI. The device is... on 2010-12-20. The reason FDA records is "This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1063-2011
Status: Terminated
Initiated: 2010-12-20
Posted: 2011-02-08
Terminated: 2011-02-09
Recalling firm: RLS Interventional Inc. dba Inrad
Product: Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad, Inc. Kentwood, MI. The device is intended for use during percutaneous biopsy and drainage procedures to obtain tissues or fluid specimens.
Product code: GAA Needle, Aspiration And Injection, Disposable
Reason for recall: This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Inrad Inc., sent an "URGENT FIELD CORRECTION" notice dated December 20, 2010 to its customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to immediately examine their inventory for the affected product. If the recalled product was in stock, the customers were told to removed the affected product from the carton and dispose of carton; to disregard carton label expiration date and reference the expiration date appearing on the pouch label only, and to complete, sign and return the attached "Carton Expiration Date" INFORMATION FORM via fax to 616-301-779 or mail to Inrad Inc., ATTN: Director RA/QA, 4375 Donker Court SE, Kentwood, MI 49512. If you have any additional questions about this action, please call 800-558-4647 extension 102.
Quantity in commerce: 250
Distribution: Nationwide Distribution: USA including states of: FL, GA, KY, NH, NJ, NM, PA , SC, WA, and WI.
Product codes and lots: 6100-7001.

Product code GAA

K813368Class IDisposable Chiba-Type NeedleDlp, Inc. / cleared 1982-01-05

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)