FDA recall Z-1113-2024

MEDLINE INDUSTRIES, LP - Northfield · Class I · device

Product

Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518H; e) KIT ULTRASOUND PIV START, REF DYNDV2445; f) NICU INSERTION & DRSG CHG TRAY, REF EBSI1306A; g) PIV BSI KIT, REF BSIPIV1010; h) ULTRASOUND GUIDED IV START KIT, REF DYNDV2465

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-1113-2024