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.
Reported: August 31, 2022 Initiated: May 25, 2022 #Z-1619-2022
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Units Affected
- a. 20 Boxes b. 1 bx
- Distribution
- US Nationwide
- Location
- Richmond, VA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: a. 20 Boxes b. 1 bx.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2022. Severity: Moderate. Recall number: Z-1619-2022.
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