Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT6135BH; 3) CIRCUMCISION TRAY , Pack Number CIT2465; 4) CIRCUMCISION TRAY , Pack Number CIT4920; 5) CIRCUMCISION TRAY , Pack Number CIT7455; 6) CIRCUMCISION TRAY , Pack Number DYNDA3045; 7) CIRCUMCISION TRAY , Pack Number DYNDL1889; 8) CIRCUMCISION TRAY , Pack Number CIT7455H ; 9) CIRCUMCISION TRAY W/1.3 CLAMP , Pack Number CIT6075; 10) CIRCUMCISON TRAY, Pack Number CIT7380; 11) HOSPITAL CIRCUMCISION T, Pack Number CIT2825; 12) CIRCUMCISION TRAY , Pack Number CIT6135A ; 13) CIRCUMCISION TRAY , Pack Number CIT6135B ; 14) NICU CIRCUMCISION SET, Pack Number CIT6900;

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.

Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.