FDA recall Z-1102-2024

MEDLINE INDUSTRIES, LP - Northfield · Class I · device

Product

MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f) GASTRIC CULTURE PACK, REF DYNJ53966AH; g) HERNIA, REF CDS982034R; h) HERNIA, REF CDS982034S; i) HERNIA PACK, REF DYNJ39331B; j) LAP APPY PACK, REF DYNJ37709J; k) LAP CHOLE CDS, REF CDS983912V; l) LAP CHOLE CDS, REF CDS983912W; m) LAP CHOLE CDS, REF CDS983912X; n) LAP CHOLE CDS, REF CDS983912Y; o) LAPAROSCOPY PACK, REF DYNJ41417J; p) LAPAROTOMY CDS-LF, REF CDS860091A; q) LOWER EXTREMITY, REF DYNJ46222M; r) MAJOR PACK, REF DYNJ80578A; s) MINOR PACK, REF DYNJ67217D; t) N L MINOR CDS, REF CDS982518O; u) N L MINOR CDS, REF CDS982518P; v) NON STERILE I&D KIT, REF DYKM1438; w) PACK,GU MINOR, REF DYNJ906885B; x) PLASTICS SUTURE TRAY, REF SUT13535; y) RESPIRATORY KIT, REF DYKM1404; z) T

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-1102-2024