FDA Device recall Z-2758-2024
Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B
- FDA Device
- Class II
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class II recall of Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B 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-2758-2024 |
| 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
Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 3) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 4) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 5) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497
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 | SPEC0300B, Lot Number 2022033050; CIT6780, Lot Number 2022042550; CIT4845, Lot Number 2022032450; MNS9865, Lot Numbe…SPEC0300B, Lot Number 2022033050; CIT6780, Lot Number 2022042550; CIT4845, Lot Number 2022032450; MNS9865, Lot Number 2022021850; MNS9865, Lot Number 2022041850; DYNDA2497, Lot Number 2022042650 |
|---|
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-2758-2024%22
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