Z-1218-2022 Class II Ongoing
FDA device recall Z-1218-2022 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Apr 21, 2022 and is designated Class II. Reason for recall: Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. The recall status is ongoing. Affected quantity: 4033 boxes of 25 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 8, 2022
- Initiation Date
- Apr 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4033 boxes of 25 units
Product Description
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
Reason for Recall
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
Distribution Pattern
US and Panama
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1218-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026