Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.
FDA Recall Z-0564-2013 · Posted 2012-12-19
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Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMF
Date Initiated2012-10-02
Date Terminated2016-05-03
Product Quantity2,786,000 units
Reason for Recall
BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.
Firm Action
Becton Dickinson sent a Urgent Product Recall letter/Customer Packing list dated October 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to review inventory and determine if they have any of the affected product. If so, it should be removed from inventory.
The enclosed customer list should be completed as well. Any questions please call 1-201-847-4267.
Root Cause
Mixed-up of materials/components
Distribution Pattern
(USA) nationwide
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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