9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath
FDA device recall Z-1035-03 · posted 2003-07-19 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- separation of sheath
- Action taken
- The recalling firm issued recall letters dated 7/9/03 to their accounts informing them of the problem and the need to return the product. To expedite product removal the recalling firm telephoned the accounts that received the complaint lot.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 13442 units
- Distribution
- The products were shipped to hospitals, distributors, dealers and sales representatives nationwide. The product was also shipped to export dealers in Finland, Australia, Italy, Brazil, Taiwan, New Zea
- Date initiated
- 2003-07-08
- Date posted
- 2003-07-19
- Date terminated
- 2004-09-02
- Location
- Reading, PA
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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 |