Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2)
Summary
The FDA issued a Class II for Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST 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-2780-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2) CIRCUMCISION KIT, Pack Number CIT6535; 3) CIRCUMCISION KIT, Pack Number CIT7095; 4) CIRCUMCISION TRAY, Pack Number CIT6860A; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCISION TRAY, Pack Number CIT6720; 7) CIRCUMCISION TRAY, Pack Number CIT7020; 8) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 9) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920
Lot/Code Info: DYNDH1512A, Lot Number 2023030190; CIT6535, Lot Number 2023090580; CIT7095, Lot Number 2020121190; CIT7095, Lot Number 2022031590; CIT6860A, Lot Number 2021111580; CIT6860A, Lot Number 2022010480; CIT6860A, Lot Number 2022041880; CIT6860A, Lot Number 2022053080; CIT6860A, Lot Number 2022062080; CIT6860A, Lot Number 2022121280; CIT6860A, Lot Number 2023032080; CIT6860A, Lot Number 2023062680; CIT6860A, Lot Number 2023071780; CIT6860A, Lot Number 2023090580; CIT6860A, Lot Number 2023091180; CIT6860A, Lot Number 2023111380; CIT6860A, Lot Number 2024020580; DYNDA2271, Lot Number 2021072890; CIT6720, Lot Number 2021080390; DYNDA2271, Lot Number 2021083190; DYNDA2271, Lot Number 2021100790; DYNDA2271, Lot Number 2022010390; CIT6720, Lot Number 2021121590; DYNDA2271, Lot Number 2022042590; CIT7020, Lot Number 2022061390; CIT6720, Lot Number 2022072790; CIT6720, Lot Number 2022091690; CIT7020, Lot Number 2022110990; CIT6720, Lot Number 2022110990; CIT6720, Lot Number 2023063090; DYNDA2271, Lot Number 2023063090; CIT7020, Lot Number 2023080890; DYNDA2271, Lot Number 2023112990; CIT7020, Lot Number 2024020890; DYNDA2271, Lot Number 2024030690; CIT6780, Lot Number 2021110350; CIT6780, Lot Number 2022070750; CIT6780, Lot Number 2022072150; CIT6780, Lot Number 2023030190; CIT6780, Lot Number 2024022890; CIT6920, Lot Number 2022042590
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-2780-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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