Device product
BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination
Z-2748-2017
Product summary
- Event
- Event 77513
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29,500 units
- Official record key
device-enforcement:Z-2748-2017
Official wording
Reason: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Code information: 6022838 2021-01
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.