MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to secure anaesthesia catheter.
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling 109 units of the MERIT MEDICAL SYSTEMS StayFIX Fixation Device (Model Number: 884450023358), which is used to secure anesthesia catheters. The devices were affected by temperature excursions between June 2021 and August 2021 at a facility prior to delivery, and all affected units were received between June 1, 2021 and September 30, 2021. The higher temperatures during storage may have impacted the product's effectiveness, though the manufacturer states this specific temperature deviation is not likely to cause adverse health consequences.
The recalled devices were distributed nationwide in the United States. Affected products can be identified by GTINs 00884450023358, 10884450023355, and 20884450023352. The source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 109 Lot/code info: GTIN: 00884450023358; 10884450023355; 20884450023352
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.