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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Procedural Trays

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  Class 2 Device Recall Sterile Procedural Trays see related information
Date Initiated by Firm November 17, 2022
Date Posted February 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-1066-2023
Recall Event ID 91386
Product Classification Cardiac catheterization kit - Product Code OES
Product Sterile Procedural Trays, labeled as the following:

a. CARDIAC CATH PACK-LF;

b. ANGIOGRAPHY-NS-LF;

c. EP BASIC SET UP PACK;

d. IMPLANT PACK-LF;

e. PORT PACEMAKER INSERTION PACK;

f. OPEN HEART PACK;

g. LAP BASIN TRAY;

h. ANGIO ACCESS;

i. ANGIO
Code Information a. CARDIAC CATH PACK-LF, Item Number: DYNJ0368386D, Case UDI/GTIN: 40889942060246, Unit UDI/GTIN: 10889942060245, Lot Number: 22IMD669; b. ANGIOGRAPHY-NS-LF, Item Number: DYNJ24913N, Case UDI/GTIN: 40195327127368, Unit UDI/GTIN: 10195327127367, Lot Number: 22JBC783; c. EP BASIC SET UP PACK, Item Number: DYNJ27920D, Case UDI/GTIN: 40884389855349, Unit UDI/GTIN: 10884389855348, Lot Number: 22IBS859; d. IMPLANT PACK-LF, Item Number: DYNJ43426C, Case UDI/GTIN: 40195327255313, Unit UDI/GTIN: 10195327255312, Lot Number: 22IBO525; e. PORT PACEMAKER INSERTION PACK, Item Number: DYNJ43506A, Case UDI/GTIN: 40888277541000, Unit UDI/GTIN: 10888277541009, Lot Number: 22IBT230; f. OPEN HEART PACK, Item Number: DYNJ43937, Case UDI/GTIN: 40888277077967, Unit UDI/GTIN: 10888277077966, Lot Number: 22HBR302; g. LAP BASIN TRAY, Item Number: DYNJ50908B, Case UDI/GTIN: 40193489997621, Unit UDI/GTIN: 10193489997620, Lot Number: 22JDA804; h. ANGIO ACCESS, Item Number: DYNJ82082, Case UDI/GTIN: 40195327167616, Unit UDI/GTIN: 10195327167615, Lot Number: 22JMA564; i. ANGIO, Item Number: DYNJ905151B, Case UDI/GTIN: 40195327219964, Unit UDI/GTIN: 10195327219963, Lot Number: 22JMG564,22IMG399;
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer Reason
for Recall		 Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
FDA Determined
Cause 2		 Device Design
Action Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
Quantity in Commerce 314 cases (719 units)
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Total Product Life Cycle TPLC 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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