Z-1619-2022 Class II Ongoing
FDA device recall Z-1619-2022 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on May 25, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: a. 20 Boxes b. 1 bx.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2022
- Initiation Date
- May 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a. 20 Boxes b. 1 bx
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.
Distribution Pattern
US Nationwide
Code Information
GTIN: a. 10364253111300; 50364253000305; 30364253111304. b. 10612479247670; 40612479247695; 20612479247684.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1619-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026