FDA Device recall Z-0155-2025
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609
- FDA Device
- Class II
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609 by Medline Industries Northfield, citing it has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0155-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-04 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) LFT HRT CATH RADIAL ACCESS-LF, REF DYNJ47667C; g) IR ARM PACK, REF DYNJ50712D; h) IR PACK, REF DYNJ67324; i) PL. CATHETERISME CARDIAQUE, REF HCT093J
Reason
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Identifiers
| code_info | a) REF DYNDH1609: UDI/DI 40193489844802 (each), 10193489844801 (case), Lot Numbers: 23LBO852; b) REF DYNJ19010I: U…a) REF DYNDH1609: UDI/DI 40193489844802 (each), 10193489844801 (case), Lot Numbers: 23LBO852; b) REF DYNJ19010I: UDI/DI 40888277858627 (each), 10888277858626 (case), Lot Numbers: 23LBK443; c) REF DYNJ29207: UDI/DI 40080196015413 (each), 10080196015412 (case), Lot Numbers: 23LBL962; d) REF DYNJ43661C: UDI/DI 40195327104353 (each), 10195327104351 (case), Lot Numbers: 23LBU931; e) REF DYNJ46746C: UDI/DI 40195327040162 (each), 10195327040161 (case), Lot Numbers: 23LBK374; f) REF DYNJ47667C: UDI/DI 40195327040179 (each), 10195327040178 (case), Lot Numbers: 23LBL629; g) REF DYNJ50712D: UDI/DI 40195327267927 (each), 10195327267926 (case), Lot Numbers: 23KBE846; h) REF DYNJ67324: UDI/DI 40193489395625 (each), 10193489395624 (case), Lot Numbers: 23LBL780; i) REF HCT093J: UDI/DI 40884389905679 (each), 10884389905678 (case), Lot Numbers: 23LBG513 |
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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-0155-2025%22
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