Recalls / —
—#164837
Product
BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
- FDA product code
- OFF — Central Venous Catheter Tray
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- Lot 17YM5936, Exp. 04/30/2019
Why it was recalled
One of the cases of product might not have been sterilized.
Root cause (FDA determination)
Process control
Action the firm took
The recalling firm's sales representative telephoned their one customer on 1/12/2018 requesting return of the product.
Recalling firm
- Firm
- Medline Industries, Inc.
- Address
- 1170 S Northpoint Blvd, Waukegan, Illinois 60085-6757
Distribution
- Distribution pattern
- The product was distributed to UT.
Timeline
- Recall initiated
- 2018-01-12
- Terminated
- 2020-07-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #164837. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.