FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc.: SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
- Recall number
- Z-1871-2017
- Recalling firm
- C.R. Bard, Inc.
- Product
- SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
- Status
- Completed
- Initiated
- 2017-03-09
- Posted
- not on file
- Terminated
- not on file
- Reason
- Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.
- Root cause
- Error in labeling
- Action
- Consignees were notified by letter on/about 03/09/2017.
- Quantity
- 5030 units
- Distribution
- 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.
- Lot, serial or model codes
- Product Code: A300316A, Lot number: NGAV2400
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EYZ
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28