PlainRecalls
FDA Devices Moderate Class II Ongoing

Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model Number: 513604

Reported: August 31, 2022 Initiated: May 25, 2022 #Z-1596-2022

Product Description

Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model Number: 513604

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

Units Affected
13 boxes
Distribution
US Nationwide
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model Number: 513604. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 13 boxes.
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-1596-2022.