McKesson Medefil Normal Saline IV Flush Syringes Recalled for Temperature Exposure
McKesson is recalling Medefil Normal Saline IV Flush Syringes (Models MIS-1130 and 191-MIS-1130) due to facility temperature excursions between June and August 2021. Products received through September 30, 2021 may have impaired effectiveness from temperature exposure prior to delivery.
What this means for you
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 precautionary recall with no reported illnesses or injuries. The source states temperature exposure 'may have impacted' product effectiveness, indicating a theoretical rather than confirmed hazard. Per the rubric, precautionary recalls without reported harm are classified as Moderate.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling certain lots of Medefil Normal Saline IV Flush Syringes (Models MIS-1130 and 191-MIS-1130) due to temperature excursions at a facility between June and August 2021. Temperature exposure prior to delivery may have compromised product effectiveness.
All lots received between June 1, 2021 and September 30, 2021 are affected. These products were distributed nationwide across the United States.
Patients and healthcare providers using these products should verify the lot numbers to determine if their syringes fall within the affected date range. If affected lots are identified, users should be aware that the product's effectiveness may be compromised.
The recalled product
- Product
- a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130. b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/CS) Model Number: 191-MIS-1130.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device — IV Supplies
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 (5)
- GTIN: a. 10364253111300
- 50364253000305
- 30364253111304. b. 10612479247670
- 40612479247695
- 20612479247684.
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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