FDA Device recall Z-3044-2024
Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B
- 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) PACK VAGINAL DELIVERY , Pack Number AM185B 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-3044-2024 |
| 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) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ; 5) LABOR & DELIVERY CDS, Pack Number CDS830039AK; 6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ; 7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ; 8) LABOR & DELIVERY, Pack Number CDS830054P ; 9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ; 10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ; 11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ; 12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ; 13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ; 14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ; 15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ; 16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ; 17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ; 18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ; 19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ; 20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ; 21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ; 22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ; 23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ; 24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ; 25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ; 26) DELIVERY CDS, Pack Number CDS830199K ; 27) DELIVERY CDS, Pack Number CDS981282O ; 28) OB PROCEDURE-LF , Pack Number CDS981335B ; 29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ; 30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ; 31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ; 32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ; 33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ; 34) VAGINAL MAJOR , Pack Number CDS982689O ; 35) VAGINAL MAJOR , Pack Number CDS982689P ; 36) VAGINAL MAJOR , Pack Number CDS982689Q ; 37) VAGINAL MAJOR , Pack Number CDS982689R ; 38) DELIVERY PROCEDURE, Pack Number CDS982761F ; 39) DELIVERY PROCEDURE, Pack Number CDS982761G ; 40) DELIVERY PROCEDURE, Pack Number CDS982761I ; 41) DELIVERY PROCEDURE, Pack Number CDS982761J ; 42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ; 43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ; 44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ; 45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ; 46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ; 47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ; 48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ; 49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ; 50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ; 51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959; 52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ; 53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ; 54) LABOR & DELIVERY CDS, Pack Number CDS983116C ; 55) LABOR & DELIVERY CDS, Pack Number CDS983116D ; 56) LABOR & DELIVERY CDS, Pack Number CDS983116F ; 57) LABOR & DELIVERY CDS, Pack Number CDS983116G ; 58) LABOR & DELIVERY CDS, Pack Number CDS983116I ; 59) MINOR VAGINAL CDS , Pack Number CDS983119B ; 60) VAGINAL MINOR , Pack Number CDS983268J ; 61) VAGINAL MINOR , Pack Number CDS983268L ; 62) GYN VAGINAL CDS , Pack Number CDS983528J ; 63) ACH MAJOR VAGINAL , Pack Number CDS983641F ; 64) ACH MAJOR VAGINAL , Pack Number CDS983641G ; 65) VAG HYST CDS, Pack Number CDS983697F ; 66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ; 67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ; 68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ; 69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ; 70) OB/GYN CDS, Pack Number CDS984173G ; 71) OB GYN, Pack Number CDS984173I ; 72) GROTH VAGINAL CDS , Pack Number CDS984201P ; 73) GROTH VAGINAL CDS , Pack Number CDS984201Q ; 74) GROTH VAGINAL CDS , Pack Number CDS984201R ; 75) GROTH VAGINAL CDS , Pack Number CDS984201U ; 76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ; 77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ; 78) VAGINAL DELIVERY CDS, Pack
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 | AM185B , Lot Number 23BBS790 ; AM185B , Lot Number 23IBT868 ; AM185B , Lot Number 23JBW874 ; AM185B , Lot Number 24A…AM185B , Lot Number 23BBS790 ; AM185B , Lot Number 23IBT868 ; AM185B , Lot Number 23JBW874 ; AM185B , Lot Number 24ABQ730 ; CDS830039AF, Lot Number 19GBO514 ; CDS830039AF, Lot Number 19HBS937 ; CDS830039AF, Lot Number 19JBM007 ; CDS830039AF, Lot Number 19VBF341 ; CDS830039AF, Lot Number 20ABQ286 ; CDS830039AF, Lot Number 20BBR820 ; CDS830039AF, Lot Number 20CBC115 ; CDS830039AF, Lot Number 20EBC561 ; CDS830039AF, Lot Number 20FBH160 ; CDS830039AF, Lot Number 20GBG417 ; CDS830039AF, Lot Number 20GBT038 ; CDS830039AF, Lot Number 20JBA496 ; CDS830039AF, Lot Number 20LBV774 ; CDS830039AF, Lot Number 21ABJ105 ; CDS830039AI, Lot Number 21HBA287 ; CDS830039AI, Lot Number 21HBG893 ; CDS830039AI, Lot Number 21IBJ983 ; CDS830039AI, Lot Number 21LBQ697 ; CDS830039AI, Lot Number 22ABA249 ; CDS830039AI, Lot Number 22CBY819 ; CDS830039AI, Lot Number 22OBB223 ; CDS830039AI, Lot Number 21CBQ656 ; CDS830039AI, Lot Number 21DBP447 ; CDS830039AI, Lot Number 21FBH085 ; CDS83003 |
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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-3044-2024%22
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