FDA Device recall Z-1871-2017
SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile
- FDA Device
- Class II
- completed
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile by C R Bard, citing misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1871-2017 |
| Classification | Class II |
| Status | completed |
| Initiated | 2017-03-09 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | C R Bard |
| Distribution | CA, CO, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, NE, NJ, NM, OH, OR, PA, RI, TN, TX, VA, WA |
Product
SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
Reason
Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.
Identifiers
| code_info | Product Code: A300316A, Lot number: NGAV2400 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1871-2017%22
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