Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Numbe
Summary
The FDA issued a Class II for Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628 by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues.
Details
Source
Device Recall
External ID
Z-1462-2025
Action Date
2025-04-02
Status
Ongoing
Category
device
Product Description
Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP A PACK, Pack Number DYNJ40647G; 7) IPMC BREAST PACK-LF, Pack Number DYNJ0665560D; 8) OCULAR PLASTICS PACK, Pack Number DYNJ40356A; 9) OCULOPLASTY PACK-LF, Pack Number DYNJ0252232U; 10) PACK MASTECTOMY COMBO CHRG, Pack Number DYNJ60232A; 11) PLASTIC GENERAL SURGERY - OSC, Pack Number DYNJ43576A; 12) PLASTIC PACK, Pack Number DYNJ00264L; 13) PLASTIC PACK, Pack Number DYNJ49742B; 14) PLASTIC PK II, Pack Number DYNJ14039B; 15) PLASTIC-GENERAL SURGERY PACK, Pack Number DYNJ09866U; 16) PLASTICS FACIAL PACK ST MARY, Pack Number DYNJ45861B; 17) PLASTICS PACK, Pack Number DYNJ68288A
Lot/Code Info: 1) Pack Number DYNJ0956628O: UDI/DI 10193489785869 (each) 40193489785860 (case), Lot Number 21BBH575A; 2) Pack Number DYNJ63577C: UDI/DI 10193489267143 (each) 40193489267144 (case), Lot Number 21BBI089A; 3) Pack Number DYNJCEN04C: UDI/DI 10193489805413 (each) 40193489805414 (case), Lot Number 21BBI544A; 4) Pack Number DYNJ60669G: UDI/DI 10889942794942 (each) 40889942794943 (case), Lot Number 21EME131A; 5) Pack Number DYNJ64670B: UDI/DI 10889942575701 (each) 40889942575702 (case), Lot Number 21IME484A; 6) Pack Number DYNJ40647G: UDI/DI 10193489270976 (each) 40193489270977 (case), Lot Number 21IMH836A; 7) Pack Number DYNJ0665560D: UDI/DI 10195327089795 (each) 40195327089796 (case), Lot Number 22CMB464A; 8) Pack Number DYNJ40356A: UDI/DI 10193489228335 (each) 40193489228336 (case), Lot Number 22JBF484Z; 9) Pack Number DYNJ0252232U: UDI/DI 10195327217334 (each) 40195327217335 (case), Lot Number 22JBG465Z; 10) Pack Number DYNJ60232A: UDI/DI 10195327222451 (each) 40195327222452 (case), Lot Number 22JBN921Z; 11) Pack Number DYNJ43576A: UDI/DI 10193489920116 (each) 40193489920117 (case), Lot Number 22JBU153Z; 12) Pack Number DYNJ00264L: UDI/DI 10193489801866 (each) 40193489801867 (case), Lot Number 22JBU265A; 13) Pack Number DYNJ49742B: UDI/DI 10195327210267 (each) 40195327210268 (case), Lot Number 22JBV346A; 14) Pack Number DYNJ14039B: UDI/DI 10193489324495 (each) 40193489324496 (case), Lot Number 22JBW642A; 15) Pack Number DYNJ09866U: UDI/DI 10195327230081 (each) 40195327230082 (case), Lot Number 22JBY434A; 16) Pack Number DYNJ45861B: UDI/DI 10193489276510 (each) 40193489276511 (case), Lot Number 22KBC920Z; 17) Pack Number DYNJ68288A: UDI/DI 10193489276510 (each) 40193489276511 (case), Lot Number 22KBC927Z
Quantity Affected: 1228 units
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-11
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 216 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-1462-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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