Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number D
Summary
The FDA issued a Class II for Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Num 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 issue.
Details
Source
Device Recall
External ID
Z-2750-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179A; 5) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179AH; 6) JSI-MUSCLE&PLASTICS PACK-LF , Pack Number DYNJ0608555P; 7) OCCULAR PLASTIC, Pack Number DYNJ901206F; 8) OCCULAR PLASTIC PACK, Pack Number CMPJ05506F; 9) OCCULOPLASTIC PACK, Pack Number DYNJ65156; 10) PLASTIC PACK, Pack Number DYNJ47842C;
Lot/Code Info: DYKM2000 , Lot Number: 21FBO406 DYKM2000 , Lot Number: 22DBI980 DYKM2000 , Lot Number: 22KBD028 DYKM2000 , Lot Number: 23JBC148 DYKM2000 , Lot Number: 24ABL480 DYKM2000 , Lot Number: 21ABM981 DYKM2000 , Lot Number: 21BBR866 DYNJ902703K, Lot Number: 21FBI191 DYNJ902703K, Lot Number: 21FBR340 DYNJ902703K, Lot Number: 22OBL867 DYNJ902703K, Lot Number: 22DBH342 DYNJ902703K, Lot Number: 22DBI420 DYNJ902703K, Lot Number: 22FBM439 DYNJ38988J , Lot Number: 23JDA299 DYNJ82179A , Lot Number: 23JDB728 DYNJ82179AH, Lot Number: 23JDB728 DYNJ0608555P , Lot Number: 23GMI735 DYNJ0608555P , Lot Number: 23KMC310 DYNJ901206F, Lot Number: 23IBC085 DYNJ901206F, Lot Number: 23LBA443 DYNJ901206F, Lot Number: 24ABY049 CMPJ05506F , Lot Number: 23HBM696 CMPJ05506F , Lot Number: 23KBK942 CMPJ05506F , Lot Number: 24ABM251 DYNJ65156, Lot Number: 21GDC910 DYNJ65156, Lot Number: 21JDA096 DYNJ65156, Lot Number: 22CDC307 DYNJ65156, Lot Number: 23BDC115 DYNJ65156, Lot Number: 23EDC523 DYNJ65156, Lot Number: 23GDA856 DYNJ47842C , Lot Number: 23HBV422
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-08
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 409 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-2750-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29