FDA Device recall Z-2708-2024
Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C
- FDA Device
- Class II
- ongoing
- Published 2024-08-28
On 2024-08-28 the FDA classified a Class II recall of Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C by Medline Industries Northfield, citing A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2708-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-22 |
| Published | 2024-08-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT, REF DYKE1516A; g) ERCP REG KIT, REF DYKM2127; h) GI PACK, REF DYKE1898; i) KIT, PEG, REG, REF DYKM2128; j) KIT,1500CC, 50CS, REF DYKM2126; k) LITHOTOMY, REF DYNJ909937; l) MAJOR BASIC, REF DYNJ909703; m) MINOR GENERAL SURGERY, REF DYNJ909940; n) SUCTION SET UP KIT, REF DYKM1187A; o) TURNOVER KIT, REF DYKC1274A; p) TURNOVER KIT MKT STRAPS, REF DYKC1309A; q) U BAR, REF DYNJ902374K
Reason
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Identifiers
| code_info | a) REF CDS984011C, UDI/DI 40889942325796 (case), 10889942325795 (unit), Lot Numbers: 22EBC452, 22FBX932, 22GBR344, 22…a) REF CDS984011C, UDI/DI 40889942325796 (case), 10889942325795 (unit), Lot Numbers: 22EBC452, 22FBX932, 22GBR344, 22HBG632, 22JBR362, 22KBE842, 23EBU748, 23KBF372; b) REF DYKM1184, UDI/DI 40888277877024 (case), 10888277877023 (unit), Lot Numbers: 22FMF770, 22HMF787, 22IMH596, 22KMH402, 22LMG049, 23AMH718, 23BME929, 23BMG061, 23DME554, 23FMI657, 23GMH363, 23IMH597, 23JMB834, 23KMD766; c) REF CDS984010B, UDI/DI 40889942279372 (case), 10889942279371 (unit), Lot Numbers: 22HBM538, 22IBT843, 22KBK453, 23ABM855, 23DBT392, 23KBL270; d) REF DYK1253578F, UDI/DI 40889942925354 (case), 10889942925353 (unit), Lot Numbers: 22FMH475, 22GMD228, 22HMH211, 22HMH348, 22LMC603, 23BMD249, 23DMB067, 23EMJ898, 23FMF457, 23GMG743, 23JME993, 23KMB182, 23LMA953 e) REF DYKE1830, UDI/DI 40195327044207 (case), 10195327044206 (unit), Lot Numbers: 22FLA559, 22GLA591, 22ILA148, 23DLA944, 23ELB067, 23FLA478, 23GLA202, 23GLB207, 23HLA568, 23KLB137; f) REF DYKE1516A, UDI/DI 40889942805748 (case), 10 |
|---|
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-2708-2024%22
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