Centurion Catheter Kits Recalled Due to Temperature Exposure
Mckesson Medical-Surgical is recalling Centurion catheter kits that were exposed to higher temperatures during facility storage prior to delivery, which may have impacted product effectiveness. All units distributed nationwide between June 1 and September 30, 2021 are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 where temperature exposure may have compromised product effectiveness. The hazard is effectiveness-related rather than safety-critical, and no incident reports are documented in the source material. It qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Mckesson Medical-Surgical is recalling Centurion catheter kits (8FR, Catalog #CKF105L). The recall involves all units distributed nationwide that were received between June 1, 2021 and September 30, 2021. The affected products are identified by GTIN 00653160044300 or 50653160044305.
The recalled catheters experienced facility temperature excursions from June through August 2021 prior to delivery. Exposure to higher temperatures may have impacted the products' effectiveness.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device — Catheter Kit
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 (2)
- GTIN: 00653160044300
- 50653160044305
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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