FDA recall Z-1103-2024

MEDLINE INDUSTRIES, LP - Northfield · Class I · device

Product

MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222; h) LAP CHOLE CDS, REF CDS983912Y; i) PLASTICS SUTURE TRAY, REF SUT13535; j) SNES ENDO KIT, REF DYKE1930A

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Distribution

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

Key facts

Status
Ongoing
Initiation date
2023-11-15
Report date
2024-03-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1103-2024