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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmOctober 09, 2024
Date PostedDecember 05, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0628-2025
Recall Event ID 95621
Product Classification General purpose dental tray - Product Code OFX
ProductMEDLINE 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
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
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall		Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.
Quantity in Commerce944 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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