MEDLINE INDUSTRIES, LP – Northfield Recall 94581
Description: Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCISION TRAY, Pack Number CIT7020; 7) CIRCUMCISION TRAY, Pack Number CIT7210; 8) CIRCUMCISION TRAY, Pack Number CIT6720A; 9) CIRCUMCISION TRAY, Pack Number CIT6665; 10) CIRCUMCISION TRAY , Pack Number CIT6050 ; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) CIRCUMCISION TRAY WITHOUT CLAM, Pack Number CIT6255 ; 13) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 14) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 15) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 16) NICU PROCEDURE TRAY , Pack Number UVT925 ; 17) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 18) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 19) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 20) SHAVE KIT, Pack Number MNS8250; 21) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 22) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496; 23) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512A; 24) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT3594 ; 25) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT170 ; 26) UMBILICAL VESSEL TRAY W/OUT CA, Pack Number UVT475
MEDLINE INDUSTRIES, LP – Northfield Recall 94581 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2752-2024 |
| Event ID | 94581 |
| Event Description | Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCISION TRAY, Pack Number CIT7020; 7) CIRCUMCISION TRAY, Pack Number CIT7210; 8) CIRCUMCISION TRAY, Pack Number CIT6720A; 9) CIRCUMCISION TRAY, Pack Number CIT6665; 10) CIRCUMCISION TRAY , Pack Number CIT6050 ; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) CIRCUMCISION TRAY WITHOUT CLAM, Pack Number CIT6255 ; 13) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 14) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 15) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 16) NICU PROCEDURE TRAY , Pack Number UVT925 ; 17) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 18) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 19) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 20) SHAVE KIT, Pack Number MNS8250; 21) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 22) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496; 23) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512A; 24) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT3594 ; 25) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT170 ; 26) UMBILICAL VESSEL TRAY W/OUT CA, Pack Number UVT475 |
| Product Type | Devices |
| Distribution | Worldwide |
| Recall 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. |
| Device Classification | 20240904 |
| Device Code Info | MNS11965A, Lot Number 2023120190; MNS12670A, Lot Number 2022030490; CIT6860A, Lot Number 2022111480; CIT6715, Lot Number 2022080190; DYNDA2271, Lot Number 2022082290; CIT7020, Lot Number 2023051290; CIT7210, Lot Number 2023073190; CIT6720A, Lot Number 2023092690; CIT6665, Lot Number 2024021990; MNS11965A, Lot Number 21CBA170 ; CIT6050 , Lot Number 22FMC986 ; CIT6050 , Lot Number 22JMG259 ; CIT6050 , Lot Number 23BMH919 ; CIT6050 , Lot Number 23CME567 ; CIT6050 , Lot Number 23HMG612 ; CIT6050 , Lot Number 23HMH514 ; CIT6050 , Lot Number 23JMI036 ; CIT6925, Lot Number 2023112190; CIT6255 , Lot Number 23BBP310 ; CIT6255 , Lot Number 23DBD372 ; CIT6255 , Lot Number 23KBD873 ; CIT6255 , Lot Number 24ABC630 ; CIT6255 , Lot Number 24ABS975 ; SPEC0300B, Lot Number 2022021001; SPEC0300B, Lot Number 2022060250; CIT6780, Lot Number 2022021001; CIT6780, Lot Number 2022060350; CIT6780, Lot Number 2023080990; CIT6920, Lot Number 2023012590; CIT6920, Lot Number 2023042490; CIT6920, Lot Number 2023080190; UVT925, Lot Number 21CBZ075 ; UVT925, Lot Number 23FMB519 ; UVT925, Lot Number 23LMB020 ; CIT4845, Lot Number 2021081850; CIT4845, Lot Number 2022122290; CIT7095, Lot Number 2023031590; MNS9865, Lot Number 2022060650; MNS8250, Lot Number 2023112290; DYNDA2497, Lot Number 2021080950; DYNDA2497, Lot Number 2021092050; DYNDA2497, Lot Number 2022030750; DYNDA2497, Lot Number 2022041150; DYNDA2497, Lot Number 2022052350; DYNDA2497, Lot Number 2022120790; DYNDA2497, Lot Number 2022120890; DYNDA2497, Lot Number 2023011290; DYNDA2497, Lot Number 2023080990; DYNDA2497, Lot Number 2023092690; DYNDA2497, Lot Number 2023120790; DYNDA2497, Lot Number 2024021990; DYNDA2496, Lot Number 2021091350; DYNDA2496, Lot Number 2023012590; DYNDH1512A, Lot Number 2022083190; DYNDH1512A, Lot Number 2022112290; DYNDH1512A, Lot Number 2022122290; DYNDH1512A, Lot Number 2023033190; UVT3594 , Lot Number 22CBX289 ; UVT3594 , Lot Number 22FBL917 ; UVT3594 , Lot Number 22JBR542 ; UVT3594 , Lot Number 23FBD767 ; UVT3594 , Lot Number 23KBA665 ; UVT3594 , Lot Number 23KBW299 ; UVT3594 , Lot Number 24ABW166 ; UVT170, Lot Number 22FBF267 ; UVT170, Lot Number 22GBH328 ; UVT170, Lot Number 22JBT833 ; UVT170, Lot Number 23ABS911 ; UVT170, Lot Number 23FBK368 ; UVT170, Lot Number 23GBR967 ; UVT170, Lot Number 23LBA508 ; UVT170, Lot Number 23LBV542 ; UVT170, Lot Number 24BBA988 ; UVT170, Lot Number 24BBO747 ; UVT170, Lot Number 21OBA615 ; UVT475, Lot Number 23CMB726 ; UVT475, Lot Number 23KMC231 ; UVT475, Lot Number 23KMJ689 ; UVT475, Lot Number 24AMB343 |
| Center Classification Date | 20240828 |
| Recall Initiation Date | 20240408 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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