Mckesson Medical-Surgical Inc. Corporate Office: a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 100

Is my product affected?

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.

• UPC 00884450394984
• UPC 00801741045011
• UPC 10801741045018
• UPC 10884450394981
• UPC 20801741045015
• UPC 20884450394988
• UPC 00801741045035
• UPC 00884450394861
• UPC 10801741045032
• UPC 10884450394868
• UPC 20801741045039
• UPC 20884450394865

Check against the official notice below — it lists the full affected range.

What happened

McKesson Medical-Surgical Inc. is recalling Merit Medical Systems Aspira Dressing Kits (Model 4991503) and Aspira Pleural/Peritoneal Drainage Kits (Aspira 100) distributed nationwide in the United States. The recall affects 123 dressing kits and 407 drainage kits that were received between June 1, 2021 and September 30, 2021. These products were exposed to temperature excursions at the facility between June and August 2021 prior to delivery, which may have impacted the effectiveness of the products.

The source document does not specify a remedy for consumers who have received these products.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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: US Nationwide Quantity: a. 123 b. 407 Lot/code info: 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)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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