FDAFDA · Food and drugs·Recall number Z-1218-2022
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
Published June 8, 2022 · Recall initiated: April 21, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US and Panama
- Lot
- DI: (01)40888277367389; All Envirolite lot numbers which have the following format on individual packaging: YYMMDD X where YY is last 2 digits of Year of production, MM is the number of the month of production, DD is the day of production and X is the leading number of the raw material batch number.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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