Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF DYNJ
FDA device recall Z-0785-2025 · posted 2024-12-30 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
- Action taken
- Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- PPB
- Quantity affected
- 1086 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
- Date initiated
- 2024-11-21
- Date posted
- 2024-12-30
- Location
- Northfield, IL
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