Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad

FDA device recall Z-1063-2011 · posted 2011-02-08 · Terminated

Recall details

Recalling firm

Inrad, Inc

Reason for recall

This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

GAA

Quantity affected

250

Distribution

Nationwide Distribution: USA including states of: FL, GA, KY, NH, NJ, NM, PA , SC, WA, and WI.

Date initiated

2010-12-20

Date posted

2011-02-08

Date terminated

2011-02-09

Location

Kentwood, MI

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