FDA Device recall Z-0161-2025
Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D
- 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: 1) CYSTO CDS, REF CDS983525D 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-0161-2025 |
| 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: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7) MINOR PACK, REF DYNJ42132A; 8) RECTAL PRONE PACK, REF DYNJ43380A; 9) HERNIA APPENDECTOMY TEGH-LF, REF DYNJ46716; 10) CYSTO PACK, REF DYNJ47821F; 11) CYSTO PACK, REF DYNJ48978C; 12) CYSTO PACK, REF DYNJ50428C; 13) MID HUDSON CYSTO PACK, REF DYNJ53418B; 14) CYSTO PACK-LF, REF DYNJ55479D; 15) CYSTO PACK, REF DYNJ58445A; 16) MINOR PACK, REF DYNJ58566B; 17) CSTM PK GEN NEW ENGL SURG, REF DYNJ59431; 18) RIDGEWOOD LAP PACK-LF, REF DYNJ60077A; 19) FLEXIBLE CYS PACK, REF DYNJ62111C; 20) CYSTO PACK, REF DYNJ65830A; 21) MAIN & ODS CYSTO PACK, REF DYNJ66821A; 22) PROCEDURE CYSTO PACK, REF DYNJ68883; 23) CYSTO PACK, REF DYNJ69729; 24) MINOR SURGERY PACK, REF DYNJ80004; 25) LAPAROSCOPY PACK, REF DYNJ80763; 26) LAPAROSCOPY PACK, REF DYNJ80763; 27) CYSTO PACK, REF DYNJ82626; 28) MINOR PACK, REF DYNJ83155; 29) SY CYSTO, REF DYNJ900583M; 30) CYSTO, REF DYNJ905569B; 31) CYSTO, REF DYNJ907541A; 32) SET UP PACK-LF, REF LLSCASET01; 33) MAJOR PACK, REF SYNJ910011B
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 | 1) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 24ABW238; 2) REF CDS983525D, UDI/…1) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 24ABW238; 2) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 23KBU714; 3) REF DYNJ25834B, UDI/DI 40193489849555 (each) 10193489849554 (case), Lot Numbers: 24ABG332; 4) REF DYNJ35569C, UDI/DI 40195327498253 (each) 10195327498252 (case), Lot Numbers: 23LBL736; 5) REF DYNJ40724D, UDI/DI 40195327420773 (each) 10195327420772 (case), Lot Numbers: 24ABG713; 6) REF DYNJ41105C, UDI/DI 40193489969659 (each) 10193489969658 (case), Lot Numbers: 24ABA628; 7) REF DYNJ42132A, UDI/DI 40195327385270 (each) 10195327385279 (case), Lot Numbers: 23LBS108; 8) REF DYNJ43380A, UDI/DI 40888277265913 (each) 10888277265912 (case), Lot Numbers: 23KBD028; 9) REF DYNJ46716, UDI/DI 40888277597069 (each) 10888277597068 (case), Lot Numbers: 23LBM976; 10) REF DYNJ47821F, UDI/DI 40193489956796 (each) 10193489956795 (case), Lot Numbers: 24ABC507; 11) REF DYNJ48978C, UDI/DI 4019532732594 |
|---|
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-0161-2025%22
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