SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
FDA device recall Z-1210-2019 · posted 2019-06-26 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.
- Action taken
- BD distributors provided a hard copy of the recall letter on February 28, 2019 via FedEx and may also be contacted via e-mail (when available). Distributors are requested to identify their customers and provide BD a customer list so that BD can undertake further communication to the users. BD will distribute the recall communication to the distributor customers via FedEx upon receiving the customer information from the distributors. A copy of the BD product recall customer letter was provided to distributors, in the case they opt to contact their customers directly. BD is requesting that customers destroy product at their location. Distributors will be asked to return product. A Customer Response Form to be completed and returned. Questions: Phone: 888-812-3266 Phone hours: 24 hours a day, 7 days a week Email: customerfeedback@bd.com
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 2900 Sets
- Distribution
- US Nationwide Distribution in the states of AR, NH, NC
- Date initiated
- 2019-02-28
- Date posted
- 2019-06-26
- Date terminated
- 2020-07-30
- Location
- Franklin Lakes, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 30-30-2 700 SYRINGE EXTENSION SET (K811885) | Y | 1981-08-25 |