Recall Z-2752-2024
MEDLINE INDUSTRIES, LP - Northfield · initiated April 8, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: 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…
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2752-2024
- Initiated
- April 8, 2024
- Posted by FDA
- August 28, 2024
- Product code
- LRP – Tray, Surgical
- Distribution
- Worldwide
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2739-2024 Class II | Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2740-2024 Class II | Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2741-2024 Class II | Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040HMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2742-2024 Class II | Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2743-2024 Class II | Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2744-2024 Class II | Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2745-2024 Class II | Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2746-2024 Class II | Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2747-2024 Class II | Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2748-2024 Class II | Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2749-2024 Class II | Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2750-2024 Class II | Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2751-2024 Class II | Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2753-2024 Class II | Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588AMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2754-2024 Class II | Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670AMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2755-2024 Class II | Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2756-2024 Class II | Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2757-2024 Class II | Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2758-2024 Class II | Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2759-2024 Class II | Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909BMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2760-2024 Class II | Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2761-2024 Class II | Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2762-2024 Class II | Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2763-2024 Class II | Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2764-2024 Class II | Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2765-2024 Class II | Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |