MEDLINE INDUSTRIES, LP - Northfield: 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.

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.

Details from the source

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. Distribution: US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution. Quantity: 1853 total Lot/code info: 1. CRANI ADD A PACK, SKU DYNJ30926O, UDI-DI 10195327539153 (EA), 40195327539154 (CASE) KIT LOTS 24AMF811 2. CRANIOTOMY, SKU CDS983611N, UDI-DI 10195327466626 (EA), 40195327466627 (CASE) KIT LOTS 23KBA720 23LBI611 23LBJ586 3. CRANIOTOMY CDS, SKU CDS983467J, UDI-DI 10195327561116 (EA), 40195327561117 (CASE) KIT LOTS 24ADA818 24ADC216 24BDA929 24DDB447 24EDA275 24EDA751 24GDB213 24IDA327 24IDB043 4. CRANIOTOMY PACK, SKU DYNJ85807A, UDI-DI 10195327637392 (EA), 40195327637393 (CASE) KIT LOTS 24CBB843 24EBC889 24GBY029 ; SKU DYNJ85927, UDI-DI 10195327575571 (EA), 40195327575572 (CASE) KIT LOTS 24BMD310 24EMI836 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A UDI-DI 10195327635466 (EA), 40195327635467 (CASE) KIT LOTS 24CMA496 24HMI081 24HMI978

UPC codes

10195327539153, 40195327539154, 10195327466626, 40195327466627, 10195327561116, 40195327561117, 10195327637392, 40195327637393, 10195327575571, 40195327575572, 10195327635466, 40195327635467

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.