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Recall Observatory FDA recall evidence

Device product

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.

Z-0564-2013

October 02, 2012

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 62394
Status
Terminated
Classification
Class II
Quantity
2,786,000 units
Official record key
device-enforcement:Z-0564-2013

Official wording

Reason: BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.

Code information: Device Listing Number - R060456 REF Lot # 305217 2076404 305217 2055156 305217 2020057 305217 2020056 305219 1346419

Distribution pattern: (USA) nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.