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FDA (Device enforcement)Recalled 2022-05-25class iii

Mckesson Medical-Surgical Inc. Corporate Office: a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate. Model Number: 122-LBXS. b. Skin Adhesive McKesson L

Is my product affected?

a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate. Model Number: 122-LBXS. b. Skin Adhesive McKesson LiquiBand Exceed 0.8 mL Liquid Precision and Dome Applicator Tip 2-Octyl Cyanoacrylate. Ref: 122-LBX. c. ADVANCED MEDICAL SOLUTIONS McKesson ADHESIVE,

  • UPC 10612479232256
  • UPC 40612479232271
  • UPC 20612479232260
  • UPC 10612479208183
  • UPC 20612479195978
  • UPC 40612479195989
  • UPC 20612479185863
  • UPC 10612479208206
  • UPC 40612479185874

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

What happened

McKesson Medical-Surgical Inc. is recalling skin adhesive products (McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate, Model Number 122-LBXS) distributed nationwide between June and September 2021. The recall was initiated because the products were exposed to temperature excursions at a facility between June and August 2021 prior to delivery, which may have impacted product effectiveness.

According to the recall record, this device with the specific storage temperature deviation is not likely to cause adverse health consequences. The source document does not specify a remedy or action for affected consumers.

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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences. Distribution: US Nationwide distribution. Quantity: a. 46.9 bx b. 75.1 bx c. 13.4 bx Lot/code info: a. UDI-DI :10612479232256; 40612479232271; 20612479232260. Lot codes distributed between July and September 2021. b. GTIN: 10612479208183; 20612479195978; 40612479195989. c. GTIN: 20612479185863; 10612479208206; 40612479185874; 20612479185863

Source

Official record: FDA (Device enforcement) ↗

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

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