FDAFDA · Food and drugs·Recall number Z-1619-2022
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.
Published August 31, 2022 · Recall initiated: May 25, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- US Nationwide
- Lot
- GTIN: a. 10364253111300; 50364253000305; 30364253111304. b. 10612479247670; 40612479247695; 20612479247684.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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