Medline Catheter Insertion Tray Recalled for Temperature Exposure During Manufacturing
Mckesson Medical-Surgical is recalling Medline catheter insertion trays (Model DYND10160) due to temperature excursions at the manufacturing facility that may have affected product effectiveness. Affected units were distributed nationwide between June and September 2021.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The documented temperature excursion has only theoretical potential impact on product effectiveness, making this a precautionary recall aligned with Moderate severity.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Medline Catheter Insertion Trays (Model DYND10160) due to temperature excursions at the manufacturing facility between June and August 2021. The trays were exposed to higher-than-appropriate temperatures prior to delivery, which may have impacted product effectiveness.
The recall affects all lots received between June 1, 2021, and September 30, 2021, nationwide. The affected units are identified by GTIN codes 10080196997091 and 40080196997092.
This FDA Class II recall was issued because facility temperature excursions may have compromised the effectiveness of the catheter insertion trays. Healthcare facilities should verify their inventory against the affected lot information.
The recalled product
- Product
- MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon Model Number: DYND10160
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 60
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: 10080196997091
- 40080196997092
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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