FDA Device recall Z-3048-2024

Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B

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) C-SECTION TRAY, Pack Number AM160B 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-3048-2024
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) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ; 3) C-SECTION CDS , Pack Number CDS820031I ; 4) C-SECTION CDS , Pack Number CDS820031J ; 5) C-SECTION PACK, Pack Number CDS820081K ; 6) C-SECTION PACK, Pack Number CDS820081L ; 7) C-SECTION CDS , Pack Number CDS820103J ; 8) C-SECTION CDS , Pack Number CDS820103K ; 9) UVALDE C-SECTION CDS, Pack Number CDS820116F ; 10) UVALDE C-SECTION CDS, Pack Number CDS820116G ; 11) C-SECTION CDS , Pack Number CDS820136O ; 12) C-SECTION CDS , Pack Number CDS820136P ; 13) C-SECTION CDS , Pack Number CDS820136Q ; 14) C-SECTION CDS , Pack Number CDS820136R ; 15) C-SECTION CDS , Pack Number CDS820136S ; 16) C-SECTION CDS , Pack Number CDS820136T ; 17) C-SECTION CDS , Pack Number CDS820136U ; 18) C-SECTION CDS , Pack Number CDS820152F ; 19) C-SECTION CDS , Pack Number CDS820152G ; 20) C-SECTION CDS , Pack Number CDS820152I ; 21) C-SECTION CDS , Pack Number CDS980774J ; 22) C-SECTION , Pack Number CDS980774K ; 23) C-SECTION , Pack Number CDS980774L ; 24) C-SECTION , Pack Number CDS980774M ; 25) C-SECTION CDS WOR-LF, Pack Number CDS981707F ; 26) C-SECTION CDS , Pack Number CDS981777L ; 27) C-SECTION CDS , Pack Number CDS981777M ; 28) C-SECTION CDS , Pack Number CDS981777N ; 29) C-SECTION CDS-LF, Pack Number CDS982258F ; 30) C-SECTION CDS-LF, Pack Number CDS982258G ; 31) C-SECTION CDS-LF, Pack Number CDS982258I ; 32) C-SECTION CDS , Pack Number CDS982267F ; 33) C-SECTION CDS , Pack Number CDS982267G ; 34) C-SECTION CDS , Pack Number CDS982267I ; 35) C-SECTION CDS , Pack Number CDS982267J ; 36) C-SECTION CDS , Pack Number CDS982328J ; 37) C-SECTION CDS , Pack Number CDS982328K ; 38) C-SECTION CDS , Pack Number CDS982328L ; 39) C-SECTION CDS , Pack Number CDS982328M ; 40) C-SECTION CDS , Pack Number CDS982328O ; 41) C-SECTION CDS , Pack Number CDS982328P ; 42) C-SECTION CDS , Pack Number CDS982367G ; 43) C-SECTION COMBINED CDS, Pack Number CDS982398G ; 44) C-SECTION COMBINED CDS, Pack Number CDS982398I ; 45) C-SECTION CDS , Pack Number CDS982416O ; 46) C SECTION CDS CHS , Pack Number CDS982739F ; 47) C SECTION CDS CHS , Pack Number CDS982739J ; 48) C-SECTION CDS , Pack Number CDS983117C ; 49) C-SECTION CDS , Pack Number CDS983117D ; 50) C-SECTION CDS , Pack Number CDS983117F ; 51) C-SECTION CDS , Pack Number CDS983117G ; 52) C-SECTION PROCEDURE , Pack Number CDS983450I ; 53) C-SECTION PROCEDURE , Pack Number CDS983450J ; 54) C-SECTION PROCEDURE , Pack Number CDS983450K ; 55) C-SECTION PROCEDURE , Pack Number CDS983450L ; 56) C-SECTION PROCEDURE , Pack Number CDS983450M ; 57) C-SECTION CDS , Pack Number CDS983523D ; 58) C-SECTION CDS , Pack Number CDS983523F ; 59) C-SECTION CDS , Pack Number CDS983523G ; 60) C-SECTION CDS-LF, Pack Number CDS983869I ; 61) C-SECTION-LF, Pack Number CDS983869J ; 62) C-SECTION CDS , Pack Number CDS983897G ; 63) C-SECTION CDS , Pack Number CDS983897I ; 64) C-SECTION CDS , Pack Number CDS983934I ; 65) C-SECTION CDS , Pack Number CDS983998C ; 66) C-SECTION DELIVERY CDS, Pack Number CDS984018; 67) C-SECTION DELIVERY CDS, Pack Number CDS984018A ; 68) C-SECTION CDS , Pack Number CDS984554B ; 69) C SECTION CDS , Pack Number CDS984616A ; 70) C-SECTION CDS , Pack Number CDS984768D ; 71) C-SECTION CDS , Pack Number CDS984768F ; 72) C-SECTION , Pack Number CDS984902G ; 73) C-SECTION , Pack Number CDS984902I ; 74) C-SECTION , Pack Number CDS984902J ; 75) C-SECTION , Pack Number CDS984902K ; 76) C-SECTION CDS , Pack Number CDS985206B ; 77) C-SECTION CDS , Pack Number CDS985257G ; 78) C-SECTION CDS , Pack Number CDS985257I ; 79) C-SECTION CDS , Pack Number CDS985257J ; 80) C-SECTION CDS , Pack Number CDS985257L ; 81) C SECTION , Pack Number CDS985505G ; 82) C-SECTION , Pack Number CDS985560N ; 83) C-SECTION SET-UP PACK , Pack Number CDSOBL122F ; 84) C-SECTION SET-UP PACK , Pack Number CDSOBL122G ; 85) C-SECTION SET-UP PACK , Pack Number CD

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	AM160B , Lot Number 19DBG798 ; AM160B , Lot Number 19DBT073 ; AM160B , Lot Number 19GBK115 ; AM160B , Lot Number 19T… AM160B , Lot Number 19DBG798 ; AM160B , Lot Number 19DBT073 ; AM160B , Lot Number 19GBK115 ; AM160B , Lot Number 19TBB002 ; AM160B , Lot Number 19IBN286 ; AM160B , Lot Number 19KBF062 ; AM160C , Lot Number 21FBM171 ; AM160C , Lot Number 20ABB878 ; AM160C , Lot Number 20BBW406 ; AM160C , Lot Number 20CBA975 ; AM160C , Lot Number 20DBD025 ; AM160C , Lot Number 20GBG950 ; AM160C , Lot Number 20HBV795 ; AM160C , Lot Number 21BBF298 ; AM160C , Lot Number 21BBF425 ; CDS820031I , Lot Number 19BBK847 ; CDS820031I , Lot Number 19CBE063 ; CDS820031J , Lot Number 21FBL439 ; CDS820031J , Lot Number 21GBE677 ; CDS820031J , Lot Number 21JBF745 ; CDS820031J , Lot Number 21JBN716 ; CDS820031J , Lot Number 21JBY908 ; CDS820031J , Lot Number 21KBP597 ; CDS820031J , Lot Number 21WBA979 ; CDS820031J , Lot Number 19DBM904 ; CDS820031J , Lot Number 19EBM237 ; CDS820031J , Lot Number 19FBO038 ; CDS820031J , Lot Number 19GBF747 ; CDS820031J , Lot Number 22IBI048 ; CDS820031J , Lot

code_info

AM160B , Lot Number 19DBG798 ; AM160B , Lot Number 19DBT073 ; AM160B , Lot Number 19GBK115 ; AM160B , Lot Number 19T…

AM160B , Lot Number 19DBG798 ; AM160B , Lot Number 19DBT073 ; AM160B , Lot Number 19GBK115 ; AM160B , Lot Number 19TBB002 ; AM160B , Lot Number 19IBN286 ; AM160B , Lot Number 19KBF062 ; AM160C , Lot Number 21FBM171 ; AM160C , Lot Number 20ABB878 ; AM160C , Lot Number 20BBW406 ; AM160C , Lot Number 20CBA975 ; AM160C , Lot Number 20DBD025 ; AM160C , Lot Number 20GBG950 ; AM160C , Lot Number 20HBV795 ; AM160C , Lot Number 21BBF298 ; AM160C , Lot Number 21BBF425 ; CDS820031I , Lot Number 19BBK847 ; CDS820031I , Lot Number 19CBE063 ; CDS820031J , Lot Number 21FBL439 ; CDS820031J , Lot Number 21GBE677 ; CDS820031J , Lot Number 21JBF745 ; CDS820031J , Lot Number 21JBN716 ; CDS820031J , Lot Number 21JBY908 ; CDS820031J , Lot Number 21KBP597 ; CDS820031J , Lot Number 21WBA979 ; CDS820031J , Lot Number 19DBM904 ; CDS820031J , Lot Number 19EBM237 ; CDS820031J , Lot Number 19FBO038 ; CDS820031J , Lot Number 19GBF747 ; CDS820031J , Lot Number 22IBI048 ; CDS820031J , Lot

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-3048-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.