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