Reported Feb 15, 2023 · Ongoing
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP…
MEDLINE INDUSTRIES, LP - Northfield
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Sterile Procedural Trays
- labeled as the followinga. 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
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Barcodes Product as published 1088994206024540889942060246CARDIAC CATH PACK-LF, Item Number: DYNJ0368386D, Case UDI/GTIN: 40889942060246, Unit UDI/ , Lot Number: 22IMD669 1019532712736740195327127368ANGIOGRAPHY-NS-LF, Item Number: DYNJ24913N, Case UDI/GTIN: 40195327127368, Unit UDI/ , Lot Number: 22JBC783 1088438985534840884389855349EP BASIC SET UP PACK, Item Number: DYNJ27920D, Case UDI/GTIN: 40884389855349, Unit UDI/ , Lot Number: 22IBS859 1019532725531240195327255313IMPLANT PACK-LF, Item Number: DYNJ43426C, Case UDI/GTIN: 40195327255313, Unit UDI/ , Lot Number: 22IBO525 1088827754100940888277541000PORT PACEMAKER INSERTION PACK, Item Number: DYNJ43506A, Case UDI/GTIN: 40888277541000, Unit UDI/ , Lot Number: 22IBT230 1088827707796640888277077967OPEN HEART PACK, Item Number: DYNJ43937, Case UDI/GTIN: 40888277077967, Unit UDI/ , Lot Number: 22HBR302 1019348999762040193489997621LAP BASIN TRAY, Item Number: DYNJ50908B, Case UDI/GTIN: 40193489997621, Unit UDI/ , Lot Number: 22JDA804 1019532716761540195327167616ANGIO ACCESS, Item Number: DYNJ82082, Case UDI/GTIN: 40195327167616, Unit UDI/ , Lot Number: 22JMA564 1019532721996340195327219964ANGIO, Item Number: DYNJ905151B, Case UDI/GTIN: 40195327219964, Unit UDI/ , Lot Number: 22JMG564,22IMG399 - Amount recalled
- 314 cases (719 units)
This recall covers 38 products
The agency filed one notice per product. You are reading one of them; the other 37 are below.
25 more are in the archive.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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