Z-0637-2025 Class II Ongoing
FDA device recall Z-0637-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Oct 9, 2024 and is designated Class II. Reason for recall: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. The recall status is ongoing. Affected quantity: 486 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 11, 2024
- Initiation Date
- Oct 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 486 units
Product Description
MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
Reason for Recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Distribution Pattern
US Nationwide distribution.
Code Information
1) REF CDS983465N, UDI/DI 10195327497309 (each) 40195327497300 (case), Lot Numbers: 24CDB460, 24BDA880, 23KDB948; 2)REF CDS983465N, UDI/DI 10195327699987 (each) 40195327699988 (case), Lot Numbers: 24EDB092, 24EDA519; 3) REF DYNJ63331D, UDI/DI UDI/DI 10195327270346 (each) 40195327270347 (case), Lot Numbers: 23LME440, 23HMI168, 23KMD370