FDA-Device2024-03-06Class I
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
MEDLINE INDUSTRIES, LP - Northfield
Hazard
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.
Sold states
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Affected count
1270 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1116-2024Don't want to check this manually?
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