Recalls / —
—#40854
Product
BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a needle covered with a sleeve.
- FDA product code
- JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K990188
- Affected lot / code info
- Catalog #364880, Lot #5076799, Exp 2/2008; #50076797, exp. 2/2008; #5976798, Exp 2/2008; #5098260, Exp 3/2008; #5112114, Exp 3/2008.
Why it was recalled
Customer complaints state the needle had separated from the hub, resulting in blood exposure and/or dislocation of the needle.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Becton Dickinson & Company
- Address
- 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815
Distribution
- Distribution pattern
- Worldwide
Timeline
- Recall initiated
- 2005-07-11
- Posted by FDA
- 2005-08-30
- Terminated
- 2006-06-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #40854. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.