—#197822

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

FDA product code: OES — Cardiac Catheterization Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: 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;

Why it was recalled

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Timeline

Recall initiated: 2022-11-17
Posted by FDA: 2023-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197822. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.