Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Reported: June 11, 2025 Initiated: April 22, 2025 #Z-1810-2025
Product Description
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Reason for Recall
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 1853 total
- Distribution
- US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 1853 total.
Why was this product recalled? ▼
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2025. Severity: Critical. Recall number: Z-1810-2025.
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