FDAFDA · Food and drugs·Recall number Z-1599-2022
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.
Published August 31, 2022 · Recall initiated: May 25, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- US Nationwide
- Lot
- GTIN: a. 00884450394984 (EA); 00801741045011 (EA); 10801741045018 (CA); 10884450394981 (CA); 20801741045015 (BX); 20884450394988 (BX). b. 00801741045035 (EA); 00884450394861 (EA); 10801741045032 (CA); 10884450394868 (CA); 20801741045039 (BX); 20884450394865 (BX)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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