Device product
Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, Pack Number DYNJ27442U ; 3) URETHROPLASTY PACK, Pack Number DYNJ39700B ; 4) RRP PACK, Pack Number DYNJ44109B ; 5) PROSTATECTOMY PACK-LF , Pack Number DYNJ66109A ; 6) PERINEAL PACK , Pack Number DYNJ69895; 7) LIVER 2018, Pack Number DYNJ905655A; 8) UROLOGY PACK, Pack Number DYNJT2255M
Z-3005-2024
Product summary
- Event
- Event 94583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-3005-2024
Official wording
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.
Code information: CDS983922F , Lot Number 19BDC122 ; CDS983922F , Lot Number 19CDC327 ; CDS983922F , Lot Number 19EDB619 ; CDS983922F , Lot Number 19HDB982 ; CDS983922F , Lot Number 19JDA589 ; CDS983922F , Lot Number 19JDC196 ; CDS983922F , Lot Number 20DDB450 ; CDS983922F , Lot Number 20FDB626 ; CDS983922F , Lot Number 20GDA441 ; CDS983922F , Lot Number 20HDA774 ; CDS983922F , Lot Number 20IDA727 ; CDS983922F , Lot Number 20JDC665 ; CDS983922F , Lot Number 21DDB315 ; DYNJ27442U , Lot Number 21HBM391 ; DYNJ27442U , Lot Number 21KBS771 ; DYNJ27442U , Lot Number 21LBY698 ; DYNJ39700B , Lot Number 20CBK667 ; DYNJ39700B , Lot Number 20DBC549 ; DYNJ39700B , Lot Number 20IMA568 ; DYNJ39700B , Lot Number 20KMA519 ; DYNJ39700B , Lot Number 20LME505 ; DYNJ39700B , Lot Number 21DMD882 ; DYNJ39700B , Lot Number 21FMC569 ; DYNJ39700B , Lot Number 21FMF531 ; DYNJ39700B , Lot Number 21GMF302 ; DYNJ39700B , Lot Number 21HMD242 ; DYNJ39700B , Lot Number 21JMH252 ; DYNJ39700B , Lot Number 21KMF491 ; DYNJ39700B , Lot Number 22AMG337 ; DYNJ44109B , Lot Number 21IMF271 ; DYNJ44109B , Lot Number 21JMD783 ; DYNJ44109B , Lot Number 21KME283 ; DYNJ66109A , Lot Number 21JBN809 ; DYNJ66109A , Lot Number 21KBC511 ; DYNJ66109A , Lot Number 22CBP867 ; DYNJ69895, Lot Number 21KBU119 ; DYNJ69895, Lot Number 22EBD392 ; DYNJ69895, Lot Number 22GBH506 ; DYNJ905655A, Lot Number 21ILA013 ; DYNJ905655A, Lot Number 21ILA926 ; DYNJ905655A, Lot Number 21JLB171 ; DYNJ905655A, Lot Number 22ALA375 ; DYNJ905655A, Lot Number 22BLA544 ; DYNJ905655A, Lot Number 22CLB377 ; DYNJ905655A, Lot Number 22ELA391 ; DYNJT2255M , Lot Number 21IMF282 ; DYNJT2255M , Lot Number 21JMC072 ; DYNJT2255M , Lot Number 21JMI117 ; DYNJT2255M , Lot Number 21KMF688 ; DYNJT2255M , Lot Number 21KMG176
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
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.