Recall Z-2761-2024
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 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;
Codes / lots: CIT6335, Lot Number 22IBT528 ; CIT6135BH, Lot Number 22OBI417 ; CIT6135BH, Lot Number 22FBX794 ; CIT6135BH, Lot Number 23CBQ475 ; CIT6135BH, Lot Number 23CBT677 ; CIT6135BH, Lot Number 23EBP345 ; CIT6135BH, Lot Number 23LBI785 ; CIT6135BH, Lot Number 24BBT038 ; CIT2465, Lot Number 21BBH212 ; CIT4920, Lot Number 22GBS036 ; CIT4920, Lot Number 22IBF469 ; CIT4920, Lot Number 23CBG366 ; CIT4920, Lot Number 23IBL492 ; CIT7455, Lot Number 23GBV732 ; DYNDA3045, Lot Number 23FBO420 ; DYNDA3045, Lot Number 23GBI869 ; DYNDA3045, Lot Number 23IBR354 ; DYNDL1889, Lot Number 23GLB117 ; DYNDL1889, Lot Number 23ILA455 ; CIT7455H , Lot Number 23GBV732 ; CIT6075, Lot Number 22DBD285 ; CIT6075, Lot Number 22EBV624 ; CIT6075, Lot Number 23ABM531 ; CIT6075, Lot Number 23CBC554 ; CIT6075, Lot Number 23CBH405 ; CIT6075, Lot Number 23EBC481 ; CIT6075, Lot Number 23EBS480 ; CIT6075, Lot Number 23FBT595 ; CIT6075, Lot Number 23IBT726 ; CIT7380, Lot Number 22GBM440 ; CIT7380, Lot Number 24BBM689 ; CIT2825, Lot Number 22JBI550 ; CIT2825, Lot Number 23BBR929 ; CIT2825, Lot Number 23GBD786 ; CIT2825, Lot Number 23IBL941 ; CIT6135A , Lot Number 21CBG443 ; CIT6135A , Lot Number 21CBG766 ; CIT6135B , Lot Number…
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-2761-2024
- Initiated
- April 8, 2024
- Posted by FDA
- August 28, 2024
- Product code
- OHG – Circumcision Tray
- 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-2752-2024 Class II | Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2)…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-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 |