MedSource IV Start Kit Recalled for Temperature-Related Effectiveness Loss
McKesson is recalling MedSource IV Start kits due to facility temperature excursions that may have compromised product effectiveness. Affected units were received between June and September 2021.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with potential functionality compromise due to temperature exposure. No illnesses or injuries have been reported, and the harm remains theoretical. Per the severity rubric, recalls involving risk-of-harm products where injury has not been reported score 3 (High).
Plain-English summary
McKesson Medical-Surgical Inc. is recalling MedSource IV Start kits with 8-inch Extension Sets, model MS-80047. The recall affects products distributed nationwide in the United States.
During June through August 2021, products at the manufacturing facility were exposed to higher than appropriate temperatures prior to shipment. These temperature excursions may have impacted the effectiveness of the IV start kits.
The affected kits were received between June 1 and September 30, 2021. Customers who received products during this period should discontinue use and contact their supplier for replacement or refund instructions.
The recalled product
- Product
- MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-exposure
- effectiveness-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 00816703021811
Distribution
Distributed nationwide across the United States.
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