MEDLINE KIT CV I II, REF DYNJ906071B
FDA device recall Z-0123-2025 · posted 2024-10-17 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
- Action taken
- Medline issued an UREGENT MEDICAL DEVICE NOTIFICATION to its consignees on 08/28/2024 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the consignee quarantine the product and response to obtain labeling to be placed on the affected inventory. Distributors are directed to notify those to whom they shipped the affected product.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OEZ
- Quantity affected
- 56 kits
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-08-28
- Date posted
- 2024-10-17
- Location
- Northfield, IL
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