SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
Reported: January 1, 2025 Initiated: November 6, 2024 #Z-0722-2025
Product Description
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
Reason for Recall
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 40 kits
- Distribution
- US Nationwide. Canada.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 40 kits.
Why was this product recalled? ▼
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2025. Severity: Moderate. Recall number: Z-0722-2025.
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