MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
FDA device recall Z-2132-2023 · posted 2023-07-12 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
- Action taken
- Medline issued a recall notice on 06/02/2023 to its consignees via USPS first class mail. The notice explained the problem with the product and requested the destruction of the product. Medline identified additional products, lots, and consignees and notified their consignees by email on 06/09/2023. Upon receipt of the submitted response form each account will receive over-labels to affix to the affected kits via FedEx overnight, if applicable. distributors were directed to notify their customers and collect the returned product and return it to Medline.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 15 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Panama.
- Date initiated
- 2023-05-18
- Date posted
- 2023-07-12
- Location
- Northfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.