FDA recall Z-3047-2024

Product

Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Number DYNDL1813; 6) CIRCUMCISION PACK , Pack Number DYNJ16826M ; 7) CIRCUMCISION PACK , Pack Number DYNJ16826N ; 8) CIRCUMCISION PACK , Pack Number DYNJ16826O ; 9) CIRCUMCISION PACK , Pack Number DYNJ38941D ; 10) CIRCUMCISION PACK , Pack Number DYNJ38941F ; 11) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471D ; 12) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471F ; 13) CRMC UNIVERSAL PACK-LF, Pack Number DYNJ61119C ; 14) D-CIRCUMCISION PACK , Pack Number DYNJ64432; 15) CIRCUMCISION PACK , Pack Number DYNJ64876A ; 16) CIRCUMCISION PACK , Pack Number DYNJ64876B ; 17) PACK,CIRCUMCISION ASC , Pack Number DYNJ906909A

Reason for recall

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.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-04-08

Report date

2024-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3047-2024