FDA (Devices) recall action 97985
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
C.R. Bard is recalling 116 BD InLay Optima Ureteral Stent Kits, 6 Fr x 30 cm, because the actual stent size may not match the product label.
C.R. Bard is recalling 116 Bard InLay Optima Ureteral Stent Kits, 6 Fr x 14 cm, because the actual stent size may not match the product label.
C.R. Bard is recalling 4,350 BD InLay Optima Ureteral Stent Kits, 4.7 Fr x 26 cm, because the actual stent size may not match the product label.
C.R. Bard is recalling 116 BD InLay Optima Ureteral Stent Kits, 8 Fr x 26 cm, because the actual stent size may not match the product label.