1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920 Intended use: Subcutaneous injection of insulin.
FDA Recall Z-0174-2012 · Posted 2011-11-07
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Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeKZH
Date Initiated2011-06-15
Date Terminated2015-07-27
Product Quantity10,230 shelf cartons (1,0230,000 syringes)
Reason for Recall
Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.
Firm Action
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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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