Z-2750-2024 Class II Ongoing

Recalled by MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

FDA device recall Z-2750-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Apr 8, 2024 and is designated Class II. 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… The recall status is ongoing.

Recall Details

Product Type
Devices
Report Date
Sep 4, 2024
Initiation Date
Apr 8, 2024
Voluntary/Mandated
Voluntary: Firm initiated

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;

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 Pattern

Worldwide

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2750-2024
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.