Enforcement Report - Week of February 6, 2013
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Product Detail
| Product Description | BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL |
|---|---|
| Recall Number | Z-0756-2013 |
| Classification | Class II |
| Code Info | Lot No. 2180434; Expiration Date: April 2013 |
| Product Distributed Qty | 2,944,700 units |
| Reason For Recall | BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints. |
Event Detail
| Event Id | 64010 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Becton Dickinson & Company |
| City | Franklin Lakes |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands. |
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