Recall Z-2329-2017
Arrow International Inc · initiated May 9, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
Codes / lots: Material number: ASK-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883
Reason for recall
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
FDA-determined cause: Packaging
Action taken
Arrow International sent an Urgent Medical Device Recall Notification Letter dated May 11, 2017, to affected customers. The firm's notification letter is requesting that customers immediately assess their current inventory and to discontinue and quarantine any product with the specific lot codes listed in the letter. In addition, customers were asked to complete the Recall Acknowledgement form and fax or email it back to Customer Service so they can receive a Returns Good Authorization Number for the product's return. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Details
- Recall number
- Z-2329-2017
- Initiated
- May 9, 2017
- Terminated
- September 17, 2018
- Product code
- DYB – Introducer, Catheter
- Quantity
- 27,485 units distributed in U.S, 4,371 units distributed internationally
- Distribution
- Worldwide Distribution - US (nationwide) and Canada
- Recalling firm
- Arrow International Inc, Reading, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2327-2017 Class II | Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide…Arrow International is recalling the affected product because the packaging may not be completely sealed… | 05/09/2017Terminated |
| Z-2328-2017 Class II | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter…Arrow International is recalling the affected product because the packaging may not be completely sealed… | 05/09/2017Terminated |
| Z-2330-2017 Class II | 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure…Arrow International is recalling the affected product because the packaging may not be completely sealed… | 05/09/2017Terminated |
| Z-2331-2017 Class II | 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure…Arrow International is recalling the affected product because the packaging may not be completely sealed… | 05/09/2017Terminated |
| Z-2332-2017 Class II | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue…Arrow International is recalling the affected product because the packaging may not be completely sealed… | 05/09/2017Terminated |
| Z-2333-2017 Class II | 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3)…Arrow International is recalling the affected product because the packaging may not be completely sealed… | 05/09/2017Terminated |
| Z-2334-2017 Class II | 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume…Arrow International is recalling the affected product because the packaging may not be completely sealed… | 05/09/2017Terminated |
| Z-2335-2017 Class II | Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen…Arrow International is recalling the affected product because the packaging may not be completely sealed… | 05/09/2017Terminated |
| Z-2336-2017 Class II | Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits…The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases… | 05/09/2017Terminated |
| Z-2337-2017 Class II | ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to…The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases… | 05/09/2017Terminated |
| Z-2338-2017 Class II | Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term…The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central… | 05/09/2017Terminated |