Bard Medical Division Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog recall — FDA Z-1241-2019
Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.
Overview of recall records associated with Bard Medical Division, including dates, categories and classifications where available.
Classification mix: Class II: 4.
Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.
Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the…
potential for urine leakage around the vent on the vented sample port
Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iodine assay level requirements to support 36 month expiration dating.
This page summarizes recall records in which the official source identifies Bard Medical Division as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.