Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety F
FDA device recall Z-0784-2010 · posted 2010-03-05 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
- Action taken
- The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 65 kits
- Distribution
- The products were shipped to distributors in GA, MD, and VA.
- Date initiated
- 2009-11-24
- Date posted
- 2010-03-05
- Date terminated
- 2012-01-18
- Location
- Reading, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 (K940079) | Arrow Intl., Inc. | 1994-11-30 |