Z-3060-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number CDS984080F
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.
Distribution Pattern
Worldwide distribution.
Code Information
CDS983874F , Lot Number 19JDA152 ; CDS983874F , Lot Number 19KDC441 ; CDS983874F , Lot Number 20ADB656 ; CDS983874F , Lot Number 20BDC710 ; CDS983874F , Lot Number 20EDA493 ; CDS983874F , Lot Number 20FDB761 ; CDS983874F , Lot Number 20JDC993 ; CDS983874F , Lot Number 21ADB720 ; CDS983874F , Lot Number 21DDA797 ; CDS983874F , Lot Number 21FDB765 ; CDS983874F , Lot Number 21HDA924 ; CDS983874F , Lot Number 21KDA957 ; CDS983874F , Lot Number 22BDA224 ; CDS983874F , Lot Number 22DDB013 ; CDS983874F , Lot Number 22GDA535 ; CDS983874F , Lot Number 22HDC091 ; CDS983874F , Lot Number 22JDA459 ; CDS983874F , Lot Number 23ADB076 ; CDS983874F , Lot Number 23DDA408 ; CDS983874F , Lot Number 23FDB732 ; CDS983874F , Lot Number 23IDA600 ; CDS983874F , Lot Number 23LDA901 ; CDS983874F , Lot Number 24CDA648 ; CDS984080F, Lot Number 23FBF618; CDS984080F, Lot Number 23EBN989; CDS984080F, Lot Number 23BBR987; CDS984080F, Lot Number 23ABH436; CDS984080F, Lot Number 23ABF537; CDS984080F, Lot Number 22IBR063; CDS984080F, Lot Number 22HBJ841