Recalls / —
—#157542
Product
VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K945070
- Affected lot / code info
- Lot No. 1470303001, 1570314802, 1470303002, 1570317701, 1470304601, 1570317702, 1470306602, 1570317703, 1470306301, 1570317704, 1470306602, 1570322001, 1470311301, 1660771501, 1470306301, 1470311302, 1470314801
Why it was recalled
Punctures in blister packaging that was detected during the packaging process.
Root cause (FDA determination)
Packaging process control
Action the firm took
BD sent an Urgent Medical Device Recall letter dated June 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use and return the affected lot to CareFusion for replacement. For recall related questions contact BD Support Center 1-888-562-6018.
Recalling firm
- Firm
- CareFusion 303, Inc.
- Address
- 10020 Pacific Mesa Blvd, San Diego, California 92121-4386
Distribution
- Distribution pattern
- Worldwide Distribution in the states of : CO, IL, IN, MD, MI, NY, OH, & TX. and foreign countries of: Australia, New Zealand, & Japan.
Timeline
- Recall initiated
- 2017-06-30
- Terminated
- 2021-02-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #157542. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.