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Recall Observatory FDA recall evidence

Device product

MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140

Z-0628-2025

October 09, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95621
Status
Ongoing
Classification
Class II
Quantity
944 units
Official record key
device-enforcement:Z-0628-2025

Official wording

Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Code information: 1) REF DYNJ52404I, UDI/DI 10195327339159 (each) 40195327339150 (case), Lot Numbers: 23HDB384, 23IDC338; 2) REF DYNJ59073B, UDI/DI 10195327200398 (each) 40195327200399 (case), Lot Numbers: 23CBG401, 22JBI913, 23GBU324, 23EBL522, 23BBA464, 23CBU743, 23IBS781; 3) REF DYNJ80226A, UDI/DI 10195327195021 (each) 40195327195022 (case), Lot Numbers: 22GBV225, 22FBV173, 22FBV174; 4) REF DYNJ83140, UDI/DI 10195327232955 (each) 40195327232956 (case), Lot Numbers: 22JBN386

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.