FDA recall Z-2634-2024

Product

Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY , Pack Number DYNDA1233B ; 4) PAIN TRAY , Pack Number DYNDA2402A ; 5) C ARM BLOCK PACK, Pack Number DYNDA2795; 6) SINGLE DOSE EPI TRAY, Pack Number DYNDA2965; 7) MAMMOGRAPHY TRAY, Pack Number DYNDH1094; 8) FTMC PAIN TRAY, Pack Number DYNDH1239D; 9) LUMBAR PUNCTURE - CHLORAPREP, Pack Number DYNDH1351B ; 10) PAIN MANAGEMENT PACK, Pack Number DYNDH1697; 11) PAIN MANAGEMENT PACK, Pack Number DYNDH1697A ; 12) EPIDURAL TRAY , Pack Number DYNDH1739; 13) PAIN MANAGEMENT TRAY, Pack Number DYNDH1823; 14) PAIN KIT MARSHFIELD , Pack Number DYNDH1842; 15) PAIN TRAY , Pack Number DYNDH1938; 16) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290C ; 17) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290D ; 18) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290F ; 19) MANAGEMENT PAIN PACK-LF , Pack Number DYNJ0377378G ; 20) MANAGEMENT PAIN PACK-LF , Pac

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

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-04-08

Report date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2634-2024