FDA Device recall Z-3004-2024
Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O 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-3004-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-08 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | n/a |
Product
Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack Number CDS981237F ; 3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ; 4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239; 5) US BREAST BIOPSY TRAY, Pack Number DYNDH1187A; 6) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286A; 7) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286AH; 8) PACK,BREAST BIOPSY, Pack Number DYNDL1498; 9) BONE MARROW PACK, Pack Number DYNJ0628436I ; 10) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035K; 11) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035KH; 12) OPP MINOR PACK-LF , Pack Number DYNJ0706869I ; 13) OPP MINOR PACK-LF , Pack Number DYNJ0706869IH; 14) BIOPSY DRAPE PACK , Pack Number DYNJ20953F ; 15) STEREOTACTIC TRAY , Pack Number DYNJ28856D ; 16) BIOPSY TRAY , Pack Number DYNJ31585C ; 17) BONE MARROW KIT PK, Pack Number DYNJ37526; 18) CT BIOPSY PACK-LF , Pack Number DYNJ38414B ; 19) CUSTOM BONE CEMENT TRAY-LF, Pack Number DYNJ42702D ; 20) LIVER TRANSPLANT PACK , Pack Number DYNJ43493A ; 21) BIOPSY TRAY , Pack Number DYNJ49368; 22) BONE MARROW HARVEST PACK, Pack Number DYNJ50740A ; 23) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550; 24) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550A ; 25) NDN CUSTOM BONE RECOVERY, Pack Number DYNJ903942D; 26) MODULE BREAST BIOPSY, Pack Number DYNJ904158B; 27) PACK,FETOSCOPY, Pack Number DYNJ906905B; 28) MINOR/BREAST BIOPSY-LF, Pack Number DYNJS3035; 29) BREAST BIOPSY-LF, Pack Number DYNJT1911D ; 30) BIOPSY TRAY , Pack Number SPEC0150 ; 31) BIOPSY TRAY W/O LIDOCAINE , Pack Number SPEC0196B; 32) STEREOTACTIC BIOPSY TRAY, Pack Number SPEC0279
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 | CDS840215O , Lot Number 21HBJ135 ; CDS840215O , Lot Number 21JBS174 ; CDS840215O , Lot Number 22ABB090 ; CDS840215O…CDS840215O , Lot Number 21HBJ135 ; CDS840215O , Lot Number 21JBS174 ; CDS840215O , Lot Number 22ABB090 ; CDS840215O , Lot Number 22ABS124 ; CDS840215O , Lot Number 22EBA066 ; CDS840215O , Lot Number 22GBQ007 ; CDS840215O , Lot Number 22GBQ009 ; CDS840215O , Lot Number 22HBU942 ; CDS840215O , Lot Number 23ABD369 ; CDS840215O , Lot Number 23CBO683 ; CDS840215O , Lot Number 23FBT988 ; CDS840215O , Lot Number 23GBI919 ; CDS840215O , Lot Number 23JBK910 ; CDS840215O , Lot Number 24ABE598 ; CDS840215O , Lot Number 20LBA006 ; CDS840215O , Lot Number 21ABQ774 ; CDS840215O , Lot Number 21ABR763 ; CDS840215O , Lot Number 21ABT392 ; CDS840215O , Lot Number 21CBM879 ; CDS840215O , Lot Number 21CBY329 ; CDS840215O , Lot Number 21DBP547 ; CDS981237F , Lot Number 19BBH974 ; CDS981237F , Lot Number 19DBZ760 ; CDS981237F , Lot Number 19GBG896 ; CDS981237F , Lot Number 19GBR697 ; CDS981237F , Lot Number 19IBK312 ; CDS981237F , Lot Number 19JBS472 ; CDS981237F , Lot Number 19VB |
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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-3004-2024%22
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