8" Extension Set with SmartSite(TM) HEP-Lock and Rotating Luer Lock. SmartSite(TM) is a trademark of Alaris Medical Syst
FDA device recall Z-1123-2010 · posted 2010-03-30 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Sterility may be compromised.
- Action taken
- The recalling firm issued an "Urgent Medical Device Recall" letter dated February 19, 2010 to their consignees to inform them of the issue. Customers were instructed to check their inventory for the affected products, cease use and distribution, and quarantine all affected product immediately. Consignees were further instructed the following: 1) Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International at 1-800-343-2935 and 2) Return all affected product to Arrow International, Inc. 312 Commerce Place, Asheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. If additional information or clarification regarding the recall is needed, please contact Arrow International, Customer Service Department at 1-800-523-8446. Details about the recall can be accessed on the firm's website at http://www.teleflexmedical.com/spotlight/ivTubingRecall/index.html.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 70,959,969 of total units
- Distribution
- Worldwide Distribution -- United States, Canada, Columbia, South Africa, Turkey, Kazakhstan, Venezuela, Germany, Cuba, Panama, El Salvador, Costa Rica, Singapore, and United Kingdom.
- Date initiated
- 2010-02-01
- Date posted
- 2010-03-30
- Date terminated
- 2012-11-08
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- (K830755) | Medical Parameters, Inc. | 1983-04-28 |