FDA-Device2025-06-11Class I
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Sold states
US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
Affected count
1853 total
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1809-2025Don't want to check this manually?
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