FDA Device recall Z-2780-2024
Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A
- FDA Device
- Class II
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class II recall of Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A by Medline Industries Northfield, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2780-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-08 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | n/a |
Product
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
Reason
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.
Identifiers
| code_info | DYNDH1512A, Lot Number 2023030190; CIT6535, Lot Number 2023090580; CIT7095, Lot Number 2020121190; CIT7095, Lot Numb…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 Numb |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2780-2024%22
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