FDA Enforcement
Class II
Terminated
Arrow¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.
Recall: Z-2287-2017
·
Reported June 14, 2017
Enforcement
- Recall Number
- Z-2287-2017
- Event ID
- 76937
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 14, 2017
- Initiation Date
- March 20, 2017
- Classification Date
- June 6, 2017
- Termination Date
- December 18, 2018
- Address
- 2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States
Description
Arrow¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.
Reason
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
Code Info
Material number ASK-04001-DU4S
Distribution
Nationwide Distribution
Quantity
unknown-firm reports total devices distributed 43,394