Recall Z-1219-2022— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2022-04-21. FDA's recall record names no specific 510(k) clearance for this event. Product: MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW. Reason: Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-04-21
- Firm location
- Northfield, IL, United States
Product description
MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.