Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
Why it was recalled
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution.
Recall record
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product type
- Devices
- Recall number
- Z-2780-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Origin
- Northfield, IL
- Recall initiated
- 2024-04-08
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2780-2024 · Source: openFDA enforcement.