FDAMay 25, 2022device

a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130. b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/CS) Model Number: 191-MIS-1130.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

What to do

FDA enforcement status: Ongoing

Brands named

mckesson medical surgical inc corporate officemckessonmckesson medical

UPCs

103642531113005036425300030530364253111304106124792476704061247924769520612479247684

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130. b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/CS) Model Number: 191-MIS-1130. — Recall Details · AllClear