Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BA
Summary
The FDA issued a Class II for Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; by MEDLINE INDUSTRIES, LP - Northfield. Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging..
Details
Source
Device Recall
External ID
Z-1066-2023
Action Date
2023-02-15
Status
Ongoing
Category
device
Product Description
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
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;
Quantity Affected: 314 cases (719 units)
Reason for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-17
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1066-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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