CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report
Centurion procedure packs, containing Caina syringes recalled
Medline Industries LP - Northfield is recalling Centurion procedure packs, containing Caina syringes, labeled as: Breast Biopsy Kit, Pack. The recall was initiated on 8 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2780-2024
- FDA event ID
- 94586
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Apr 2024
- FDA classified
- 28 Aug 2024
- Reported
- 4 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Syringes & Needles
Timeline
| 8 Apr 2024 | Recall initiated by company | |
| 28 Aug 2024 | Classified by FDA | +142 days |
| 4 Sep 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 94586This product is part of a recall event; the main page for the event is Centurion procedure packs, containing Caina syringes recalled.
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