Z-2442-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,679,067 units in total
Product Description
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040; 6) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA2097; 7) PAIN TRAY, Pack Number DYNJRA2230; 8) CONTINUOUS EPIDURAL, Pack Number PAIN1766A; 9) CONTINUOUS/CSE TRAY, Pack Number PAIN1856; 10) CONTINUOUS/CSE TRAY, Pack Number PAIN1856A; 11) 20G SINGLE DOSE EPIDURAL, Pack Number PAIN2047; 12) 20G SINGLE DOSE EPIDURAL/CHLOR, Pack Number PAIN2048
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: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.
Code Information
DYNJRA0960C , Lot Number 23CBH823 ; DYNJRA0960C , Lot Number 23EBC905 ; DYNJRA0960C , Lot Number 23EBV028 ; DYNJRA0960C , Lot Number 23HBO071 ; DYNJRA0960C , Lot Number 24BBI322 ; DYNJRA1268C , Lot Number 22GLB081 ; DYNJRA1268C , Lot Number 22HLA566 ; DYNJRA1268C , Lot Number 22ILA092 ; DYNJRA1268C , Lot Number 22LLA800 ; DYNJRA1268C , Lot Number 23DLA368 ; DYNJRA1268C , Lot Number 23FLA942 ; DYNJRA1268C , Lot Number 23GLA321 ; DYNJRA1268C , Lot Number 23HLA910 ; DYNJRA1268C , Lot Number 23ILA593 ; DYNJRA1638C , Lot Number 23EBA854 ; DYNJRA1638C , Lot Number 23GBE493 ; DYNJRA1638C , Lot Number 23KBJ159 ; DYNJRA1928 , Lot Number 22EBD354 ; DYNJRA1928 , Lot Number 22JBO947 ; DYNJRA1928 , Lot Number 23CBO440 ; DYNJRA1928 , Lot Number 23HBK783 ; DYNJRA1928 , Lot Number 23JBI435 ; DYNJRA1928 , Lot Number 23LBM602 ; DYNJRA1928 , Lot Number 24ABQ693 ; DYNJRA2040 , Lot Number 23CBH893 ; DYNJRA2040 , Lot Number 23HBX547 ; DYNJRA2040 , Lot Number 23JBN538 ; DYNJRA2040 , Lot Number 24ABQ696 ; DYNJRA2040 , Lot Number 24CBG746 ; DYNJRA2097 , Lot Number 23BBO995 ; DYNJRA2230 , Lot Number 23JBU321 ; DYNJRA2230 , Lot Number 23LBC389 ; PAIN1766A , Lot Number 23FLB123 ; PAIN1766A , Lot Number 23GLA313 ; PAIN1766A , Lot Number 24ALA302 ; PAIN1766A , Lot Number 24BLA659 ; PAIN1766A , Lot Number 24BLA888 ; PAIN1766A , Lot Number 24BLA889 ; PAIN1766A , Lot Number 24BLA998 ; PAIN1766A , Lot Number 24CLA003 ; PAIN1766A , Lot Number 24CLA078 ; PAIN1856 , Lot Number 22JLB162 ; PAIN1856 , Lot Number 22LLA409 ; PAIN1856A , Lot Number 23HLB303 ; PAIN1856A , Lot Number 24BLB005 ; PAIN1856A , Lot Number 24BLA682 ; PAIN2047 , Lot Number 24BBH932 ; PAIN2048 , Lot Number 24BBF612