Medline Catheter Plugs Recalled for Potential Temperature Exposure Impact
Mckesson Medical-Surgical is recalling Medline catheter plugs (Model DYND12200) due to temperature excursions that may have impacted effectiveness. All lots received 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 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: No illnesses or injuries have been reported. The hazard is theoretical—temperature may have impacted effectiveness, but actual product failure is unconfirmed. Per the severity rubric, recalls without reported harm and theoretical hazards score Moderate (2).
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Medline brand catheter plugs with covers (Model DYND12200) distributed nationwide. The recall affects all units that were received between June 1, 2021, and September 30, 2021.
The recalled products were exposed to facility temperature excursions that occurred between June and August 2021 prior to delivery. Exposure to higher temperatures during this period may have impacted the products' effectiveness. This recall was issued to address potential quality concerns from this temperature exposure.
Consumers and healthcare providers who received affected units should contact Mckesson Medical-Surgical Inc. for further information on the recall. The GTIN codes 10080196030873 and 40080196030874 can be used to help identify potentially affected inventory. No illnesses or injuries have been reported related to this recall.
The recalled product
- Product
- MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Model Number: DYND12200
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 1
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: 10080196030873
- 40080196030874
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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