Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS
Summary
The FDA issued a Class II for Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A 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-2752-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCISION TRAY, Pack Number CIT7020; 7) CIRCUMCISION TRAY, Pack Number CIT7210; 8) CIRCUMCISION TRAY, Pack Number CIT6720A; 9) CIRCUMCISION TRAY, Pack Number CIT6665; 10) CIRCUMCISION TRAY , Pack Number CIT6050 ; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) CIRCUMCISION TRAY WITHOUT CLAM, Pack Number CIT6255 ; 13) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 14) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 15) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 16) NICU PROCEDURE TRAY , Pack Number UVT925 ; 17) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 18) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 19) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 20) SHAVE KIT, Pack Number MNS8250; 21) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 22) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496; 23) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512A; 24) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT3594 ; 25) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT170 ; 26) UMBILICAL VESSEL TRAY W/OUT CA, Pack Number UVT475
Lot/Code Info: MNS11965A, Lot Number 2023120190; MNS12670A, Lot Number 2022030490; CIT6860A, Lot Number 2022111480; CIT6715, Lot Number 2022080190; DYNDA2271, Lot Number 2022082290; CIT7020, Lot Number 2023051290; CIT7210, Lot Number 2023073190; CIT6720A, Lot Number 2023092690; CIT6665, Lot Number 2024021990; MNS11965A, Lot Number 21CBA170 ; CIT6050 , Lot Number 22FMC986 ; CIT6050 , Lot Number 22JMG259 ; CIT6050 , Lot Number 23BMH919 ; CIT6050 , Lot Number 23CME567 ; CIT6050 , Lot Number 23HMG612 ; CIT6050 , Lot Number 23HMH514 ; CIT6050 , Lot Number 23JMI036 ; CIT6925, Lot Number 2023112190; CIT6255 , Lot Number 23BBP310 ; CIT6255 , Lot Number 23DBD372 ; CIT6255 , Lot Number 23KBD873 ; CIT6255 , Lot Number 24ABC630 ; CIT6255 , Lot Number 24ABS975 ; SPEC0300B, Lot Number 2022021001; SPEC0300B, Lot Number 2022060250; CIT6780, Lot Number 2022021001; CIT6780, Lot Number 2022060350; CIT6780, Lot Number 2023080990; CIT6920, Lot Number 2023012590; CIT6920, Lot Number 2023042490; CIT6920, Lot Number 2023080190; UVT925, Lot Number 21CBZ075 ; UVT925, Lot Number 23FMB519 ; UVT925, Lot Number 23LMB020 ; CIT4845, Lot Number 2021081850; CIT4845, Lot Number 2022122290; CIT7095, Lot Number 2023031590; MNS9865, Lot Number 2022060650; MNS8250, Lot Number 2023112290; DYNDA2497, Lot Number 2021080950; DYNDA2497, Lot Number 2021092050; DYNDA2497, Lot Number 2022030750; DYNDA2497, Lot Number 2022041150; DYNDA2497, Lot Number 2022052350; DYNDA2497, Lot Number 2022120790; DYNDA2497, Lot Number 2022120890; DYNDA2497, Lot Number 2023011290; DYNDA2497, Lot Number 2023080990; DYNDA2497, Lot Number 2023092690; DYNDA2497, Lot Number 2023120790; DYNDA2497, Lot Number 2024021990; DYNDA2496, Lot Number 2021091350; DYNDA2496, Lot Number 2023012590; DYNDH1512A, Lot Number 2022083190; DYNDH1512A, Lot Number 2022112290; DYNDH1512A, Lot Number 2022122290; DYNDH1512A, Lot Number 2023033190; UVT3594 , Lot Number 22CBX289 ; UVT3594 , Lot Number 22FBL917 ; UVT3594 , Lot Number 22JBR542 ; UVT3594 , Lot Number 23FBD767 ; UVT3594 , Lot Number 23KBA665 ; UVT3594 , Lot Number 23KBW299 ; UVT3594 , Lot Number 24ABW166 ; UVT170, Lot Number 22FBF267 ; UVT170, Lot Number 22GBH328 ; UVT170, Lot Number 22JBT833 ; UVT170, Lot Number 23ABS911 ; UVT170, Lot Number 23FBK368 ; UVT170, Lot Number 23GBR967 ; UVT170, Lot Number 23LBA508 ; UVT170, Lot Number 23LBV542 ; UVT170, Lot Number 24BBA988 ; UVT170, Lot Number 24BBO747 ; UVT170, Lot Number 21OBA615 ; UVT475, Lot Number 23CMB726 ; UVT475, Lot Number 23KMC231 ; UVT475, Lot Number 23KMJ689 ; UVT475, Lot Number 24AMB343
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-2752-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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