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MEDLINE INDUSTRIES, LP – Northfield Recall 89795

Description: Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.

MEDLINE INDUSTRIES, LP – Northfield Recall 89795 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0898-2022
Event ID89795
Event DescriptionExcelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
Product TypeDevices
DistributionUS Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.
Quantity7,800 pouched syringes
Recall ReasonSterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
Device Classification20220413
Device Code InfoLot #3139133, Exp. 11/01/2022.
Center Classification Date20220408
Recall Initiation Date20220304
Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Initial Notification Letter
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