BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a needle covered with a sleeve.
FDA device recall Z-1423-05 · posted 2005-08-30 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Customer complaints state the needle had separated from the hub, resulting in blood exposure and/or dislocation of the needle.
- Action taken
- A customer communication was sent by first class mail on 7/26/05, advising all consignees of the problem. The letter asks each customer to immediately examine their inventory for affected lot numbers, return product from affected lots using enclosed label and packing slip, and to notify all of their affected customers to alert them to the situation.
- Root cause
- Other
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 641200 eaches
- Distribution
- Worldwide
- Date initiated
- 2005-07-11
- Date posted
- 2005-08-30
- Date terminated
- 2006-06-29
- Location
- Franklin Lakes, NJ
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| INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1 (K990188) | Intuitive Surgical, Inc. | 1999-04-01 |