FDA-Device2022-08-31Class II

a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301.

Mckesson Medical-Surgical Inc. Corporate Office
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.

Sold states
US Nationwide
Affected count
a. 123 b. 407
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1599-2022

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