—#104880

Product

1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920 Intended use: Subcutaneous injection of insulin.

FDA product code: KZH — Introducer, Syringe Needle
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K024112
Affected lot / code info: K024112 D039612 Catalog Number 329424 Lot Number 0039920

Why it was recalled

Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

The firm, BD, sent an "PRODUCT RECALL NOTIFICATION" letter and response form dated June 15, 2011 to their consignee/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately review their inventory for the affected product, remove the product from inventory, quarantine the product and return it to BD; if the product was further distributed, they should identify their customers and notify them at once, and complete and return the attached Tracking/Verification Form via fax to: 201-847-4853. If you have any questions, contact Customer Service at 1-800-237-2762, Monday -Thursday, 8:00am-6:30pm and on Friday, 8:00-5:30pm Eastern Standard Time.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2011-06-15
Posted by FDA: 2011-11-07
Terminated: 2015-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104880. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.