Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch compon
Summary
The FDA issued a Class II for Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #AC by MEDLINE INDUSTRIES, LP - Northfield. Reason: Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fa.
Details
Source
Device Recall
External ID
Z-2232-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
Product Description
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Sterile. c. Medline Code Cart Drawer 2 Adlt Peds, Pack #ACC010366A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Sterile. d. Medline Drawer 2, Pack #ACC010375A, containing a Pure Pouch component Reorder #TRI67630, Sterile Straight Mayo Scissors, 5.5" and Sterile Magill Forceps, Reorder #66790. e. Medline Adult Drawer 4, Pack #ACC010389C, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. f. Medline Code Cart Drawer 1 Adult Airwa, Pack #ACC010451A, containing a Pure Pouch component Sterile Magill Forceps, Reorder #66790. g. Medline Emergency Airway Drawer, Pack #ACC010492, containing a Pure Pouch component Sterile Magill Forceps, Reorder #66790. h. Medline Drawer 2, Pack #ACC010681, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile and Sterile Magill Forceps, Reorder #66790. i. Medline Drawer 2, Pack #ACC010690, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. j. Medline Drawer Two #IMF 109694, Pack #ACCVB1000A, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. k. Medline First Hlth Moore Bronchoscopy, Pack #DYK1015098B4, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. l. Medline Trunk Kit 1EA, Pack #DYKM2013A, containing a Pure Pouch component #DYNJ04048, Kelly Forceps/STD STR Sterile. m. Medline Difficult Kit, Pack #DYKM2135, containing a Pure Pouch component Sterile Curved Kelly Hemostat, Reorder #66175 and Sterile Magill Forceps, Reorder #66790. n. Medline Wound Care Kit, Pack #DYNDW1033B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile.
Lot/Code Info: a. Pack #ACC010254B - Lot numbers 23KDB117, exp. 11/3/2024, and 23GDC173, exp. 6/30/2024, UDI-DI each-10193489651683 and UDI-DI case-40193489651684. b. Pack ACC010365A - Lot number23EDA386, exp. 12/31/2024, UDI-DI each 10195327063245 and UDI-DI case-40195327063246. c. Pack #ACC010366A - Lot number 23EDB861, exp. 1/31/2024, UDI-DI each 10195327063252 and UDI-DI case 40195327063253. d. Pack #ACC010375A - Lot numbers 23LDB985, exp. 6/30/2025; 23HDB243, exp. 3/31/2024, UDI-DI each-10193489890983 and UDI-DI case-40193489890984. e. Pack #ACC010389C - Lot numbers 24ADB277, exp. 3/31/2025; 23LDA035, exp. 3/31/2025; and 23HDC448, exp. 6/30/2024, UDI-DI each 10193489472493 and UDI-DI case-40193489472494. f. Pack #ACC010451A - Lot number 23HDB718, exp. 3/31/2025, UDI-DI each 10193489844849 and UDI-DI case 40193489844840. g. Pack #ACC010492 - Lot numbers 23IDA433, exp. 6/30/2024; 23HDC689, exp. 6/30/2024; and 23HDA419, exp. 5/30/2024; UDI-DI each-10193489481983 and UDI-DI case 40193489481984. h. Pack #ACC010681 - Lot numbers 24ADA608, exp. 7/31/2025; and 23HDB308, exp. 6/30/2025, UDI-DI each 10195327399665 and UDI-DI case-40195327399666. i. Pack #ACC010690 - Lot number 23IDB053, exp. 6/30/2024, UDI-DI each 10195327433307 and UDI-DI case-40195327433308. j. Pack #ACCVB1000A - Lot numbers 24ADB906, exp. 12/31/2024; 23KDC115, exp. 2/28/2025; 23IDB740, exp. 6/30/2024; and 23EDA442, ex. 5/31/2024; UDI-DI each-10195327345884 and UDI-DI case-40195327345885. k. Pack #DYK1015098B4 - Lot numbers 23IBA570, exp. 8/31/2026, and 23GBP526, exp. 8/31/2026, UDI-DI each 10884389250853 and UDI-DI case 40884389250854. l. Pack #DYKM2013A - Lot numbers 23KBH011, 23IBJ540, 23HBP844, 23HBE308, 23GBT102, and 23FBS539, all with exp. dates of 7/31/2024, UDI-DI each-10195327419868 and UDI-DI case-40195327419869. m. Pack #DYKM2135 - Lot numbers 24ABP810, 23EBJ055, and 23DBH351, all with exp. dates of 8/31/2025, UDI-DI each-10195327075798 and UDI-DI case-40195327075799. n. Pack #DYNDW1033B - Lot numbers 23LME845, exp. 4/30/2025; 23KMD933, exp. 4/30/2025, and 23GMF688, exp. 1/31/2025, UDI-DI each-10888277079182 and UDI-DI case-40888277079183.
Quantity Affected: 7,673 total non-sterile kits
Reason for Recall
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Distribution
US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-14
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 147 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-2232-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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