FDA recall Z-2987-2024

Product

Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ; 2) EPIDURAL CSTM PACK-LF , Pack Number DYNJ0844004; 3) CUSTOM EPIDURAL PACK-LF , Pack Number DYNJ0934752F ; 4) EPIDURAL PACK-LF, Pack Number DYNJ0957053D ; 5) EPIDURAL PACK-LF, Pack Number DYNJ0957053DH; 6) SINGLE SHOT TRAY, Pack Number DYNJ32736; 7) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352A ; 8) SINGLE SHOT EPIDURAL-LF , Pack Number DYNJ36046A ; 9) PHOENIXVILLE EPIDURAL TRAY, Pack Number DYNJ40991A ; 10) UNIVERSAL SCOPE PACK, Pack Number DYNJ45052A ; 11) SPINAL PACK , Pack Number DYNJ48916B ; 12) PUH SPINAL BLOCK TRAY , Pack Number DYNJ49205B ; 13) EPIDURAL PACK , Pack Number DYNJ50772A ; 14) TRANSFORAMINAL PACK , Pack Number DYNJC3420D ; 15) EPIDURAL PREP TRAY-LF , Pack Number DYNJRA0135B; 16) SUPPORT TRAY-LF, Pack Number DYNJRA0198; 17) SPINAL TRAY W/GERTIE MARX NDL , Pack Number DYNJRA0245 ; 18) EPIDURAL TRAY , Pack Number DYNJRA0260 ; 19) SPINAL EPIDURAL

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

2024-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2987-2024