Recall Z-0658-2018
Arrow International Inc · initiated October 17, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
Codes / lots: Lot numbers: Product Code AK-22142-CDC: 13F17A0021 13F17A0315 Product Code AK-22142-F: 13F17B0338 13F17E0067 Product Code AK-25142-CDC: 13F17E0340 Product Code AK-25142-F: 13F17A0207
Reason for recall
These finished good kits may contain the incorrect Springwire Guide (SWG).
FDA-determined cause: Process control
Action taken
On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.
Details
- Recall number
- Z-0658-2018
- Initiated
- October 17, 2017
- Posted by FDA
- February 20, 2018
- Terminated
- April 14, 2020
- Product code
- MPB – Catheter, Hemodialysis, Non-Implanted
- Quantity
- 5,926 total
- Distribution
- Distribution US Nationwide
- Recalling firm
- Arrow International Inc, Reading, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0647-2018 Class II | Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit…These finished good kits may contain the incorrect Springwire Guide (SWG). | 10/17/2017Terminated |
| Z-0648-2018 Class II | Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps…These finished good kits may contain the incorrect Springwire Guide (SWG). | 10/17/2017Terminated |
| Z-0649-2018 Class II | Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit…These finished good kits may contain the incorrect Springwire Guide (SWG). | 10/17/2017Terminated |
| Z-0650-2018 Class II | Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates…These finished good kits may contain the incorrect Springwire Guide (SWG). | 10/17/2017Terminated |
| Z-0651-2018 Class II | Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip…These finished good kits may contain the incorrect Springwire Guide (SWG). | 10/17/2017Terminated |
| Z-0652-2018 Class II | Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety…These finished good kits may contain the incorrect Springwire Guide (SWG). | 10/17/2017Terminated |
| Z-0653-2018 Class II | Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit…These finished good kits may contain the incorrect Springwire Guide (SWG). | 10/17/2017Terminated |
| Z-0654-2018 Class II | Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp.…These finished good kits may contain the incorrect Springwire Guide (SWG). | 10/17/2017Terminated |
| Z-0655-2018 Class II | AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and…These finished good kits may contain the incorrect Springwire Guide (SWG). | 10/17/2017Terminated |
| Z-0656-2018 Class II | ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code:…These finished good kits may contain the incorrect Springwire Guide (SWG). | 10/17/2017Terminated |
| Z-0657-2018 Class II | Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301…These finished good kits may contain the incorrect Springwire Guide (SWG). | 10/17/2017Terminated |