Recalls / —
—#154167
Product
SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
- FDA product code
- EYZ — System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- Device class
- Class 1
- Medical specialty
- Gastroenterology, Urology
- Affected lot / code info
- Product Code: A300316A, Lot number: NGAV2400
Why it was recalled
Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.
Root cause (FDA determination)
Error in labeling
Action the firm took
Consignees were notified by letter on/about 03/09/2017.
Recalling firm
- Firm
- C.R. Bard, Inc.
- Address
- 8195 Industrial Blvd NE, Covington, Georgia 30014-1497
Distribution
- Distribution pattern
- CA, CO, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, NE, NJ, NM, OH, OR, PA, RI, TN, TX, VA and WA.
Timeline
- Recall initiated
- 2017-03-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #154167. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.