Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHRO
Summary
The FDA issued a Class II for Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROG 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-2776-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY KIT, Pack Number DYNDH1512; 5) CIRCUMCISION KIT, Pack Number CIT6535; 6) CIRCUMCISION KIT, Pack Number CIT7095; 7) CIRCUMCISION TRAY, Pack Number CIT7020; 8) CIRCUMCISION TRAY, Pack Number CIT6720; 9) CIRCUMCISION TRAY, Pack Number CIT6715; 10) CIRCUMCISION TRAY, Pack Number CIT7210; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) DISPOSABLE NICU UMBILICAL INSERTION TRAY, Pack Number UVT1030; 13) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 14) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 15) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 16) PUNCH BIOPSY KIT, Pack Number MNS8245; 17) RETINAL INJECTION KIT, Pack Number MNS12465; 18) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496
Lot/Code Info: DYNDH1446A, Lot Number 2020102990; MNS11965A, Lot Number 2021061190; MNS11965A, Lot Number 2021072690; MNS11965A, Lot Number 2021083090; MNS11965A, Lot Number 2022041390; MNS11965A, Lot Number 2022091490; MNS11965A, Lot Number 2023041090; MNS12670A, Lot Number 2023060290; DYNDH1512, Lot Number 2021100490; CIT7095, Lot Number 2021061190; CIT6535, Lot Number 2024031880; CIT7020, Lot Number 2021120990; CIT6720, Lot Number 2022032290; CIT6715, Lot Number 2022062290; CIT7210, Lot Number 2022071990; CIT7020, Lot Number 2022091490; CIT7210, Lot Number 2022120590; CIT6715, Lot Number 2023012490; CIT7020, Lot Number 2023030290; CIT7210, Lot Number 2023030990; CIT7210, Lot Number 2023060290; CIT6925, Lot Number 2021081190; CIT6925, Lot Number 2021090290; CIT6925, Lot Number 2022070590; UVT1030, Lot Number 2021072190; UVT1030, Lot Number 2022032290; CIT6780, Lot Number 2021081650; CIT6780, Lot Number 2023092290; CIT6920, Lot Number 2024020290; CIT4845, Lot Number 2023042090; CIT4845, Lot Number 2023070390; CIT4845, Lot Number 2023081090; MNS8245, Lot Number 2022111890; MNS12465, Lot Number 2022072290; MNS12465, Lot Number 2022111890; MNS12465, Lot Number 2023042890; MNS12465, Lot Number 2023102390; MNS12465, Lot Number 2024022190; MNS12465, Lot Number 2024030790; MNS12465, Lot Number 2022022880; DYNDA2496, Lot Number 2023102590
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.
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-2776-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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