Recall Z-2761-2024— 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: 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;. 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
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;
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.