Peritoneal Lavage Kits, Model number AK-09000
FDA device recall Z-1408-04 · posted 2004-08-25 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- wrong introducer needle in some kits
- Action taken
- The recalling firm issued a recall letter to their customers on 8/9/04. The letter instructed the accounts to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- GBW
- Quantity affected
- 9100 units
- Distribution
- The product was shipped to 45 distributors, 265 medical facilities nationwide, 7 firm sales representatives, 12 government accounts, and 9 foreign accounts.
- Date initiated
- 2004-08-02
- Date posted
- 2004-08-25
- Date terminated
- 2005-08-22
- Location
- Reading, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW PERITONEAL LAVAGE CATHERIZATION K (K811627) | Arrow Intl., Inc. | 1981-08-10 |