Z-0638-2025 Class II Ongoing
FDA device recall Z-0638-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on October 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: 66 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- October 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66 units
Product Description
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
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 DYNJ80686A, UDI/DI 10195327560645 (each) 40195327560646 (case), Lot Numbers: 24CBR604, 24CBA831; 2) REF DYNJ84667, UDI/DI 10195327396329 (each) 40195327396320 (case), Lot Numbers: 23KBO980