Recall Z-2776-2024— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-04-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY KIT, Pack Number DYNDH1512; 5) CIRCUMCISION KIT, Pack Number CIT6535; 6) CIRCUMCISION KIT, Pack Number CIT7095; 7) CIRCUMCISION TRAY, Pack Number CIT7020; 8) CIRCUMCISION TRAY, Pack Number CIT6720; 9) CIRCUMCISION TRAY, Pack Number CIT6715; 10) CIRCUMCISION TRAY, Pack Number CIT7210; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) DISPOSABLE NICU UMBILICAL INSERTION TRAY, Pack Number UVT1030; 13) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 14) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 15) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 16) PUNCH BIOPSY KIT, Pack Number MNS8245; 17) RETINAL INJECTION KIT, Pack Number MNS12465; 18) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496. 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..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-08
- Firm location
- Northfield, IL, United States
Product description
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY KIT, Pack Number DYNDH1512; 5) CIRCUMCISION KIT, Pack Number CIT6535; 6) CIRCUMCISION KIT, Pack Number CIT7095; 7) CIRCUMCISION TRAY, Pack Number CIT7020; 8) CIRCUMCISION TRAY, Pack Number CIT6720; 9) CIRCUMCISION TRAY, Pack Number CIT6715; 10) CIRCUMCISION TRAY, Pack Number CIT7210; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) DISPOSABLE NICU UMBILICAL INSERTION TRAY, Pack Number UVT1030; 13) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 14) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 15) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 16) PUNCH BIOPSY KIT, Pack Number MNS8245; 17) RETINAL INJECTION KIT, Pack Number MNS12465; 18) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.