Recall Z-1619-2022— Mckesson Medical-Surgical Inc. Corporate Office

Name: FDA recall Z-1619-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-25

Class II · Ongoing

Class II FDA medical device recall by Mckesson Medical-Surgical Inc. Corporate Office, initiated 2022-05-25. It names one FDA 510(k) clearance: K091583. Product: 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: 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..

Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Classification: Class II
Status: Ongoing
Initiated: 2022-05-25
Firm location: Richmond, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K091583 — MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGEMedefil, Inc.·cleared 2010-01-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.