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Recall Observatory FDA recall evidence

Device product

MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS

Z-1221-2022

April 21, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 90125
Status
Ongoing
Classification
Class II
Quantity
699 boxes of 50 units
Official record key
device-enforcement:Z-1221-2022

Official wording

Reason: Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.

Code information: DI: (01) 40888277367396; 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.

Distribution pattern: US and Panama

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination