Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Inrad sample master aspiration biopsy needle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Inrad sample master aspiration biopsy needle see related information
Date Initiated by Firm December 20, 2010
Date Posted February 08, 2011
Recall Status1 Terminated 3 on February 09, 2011
Recall Number Z-1063-2011
Recall Event ID 57531
510(K)Number K813368  
Product Classification Needle, aspiration and injection, disposable - Product Code GAA
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.
Code Information 6100-7001.
Recalling Firm/
Manufacturer		 Inrad, Inc
4375 Donkers Ct Se
Kentwood MI 49512-4054
For Additional Information Contact Melissa Lalomia
616-301-7800
Manufacturer Reason
for Recall		 This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GAA and Original Applicant = DLP, INC.
-
-