FDA Recalls Heparin Sodium Prefilled Syringes Due to Heat Damage
Mckesson Medical-Surgical Inc. is recalling Excelsior Heparin Sodium prefilled syringes that may have been damaged by temperature excursions during manufacturing, potentially affecting their effectiveness. The recall covers lots received between June and September 2021.
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 recall with no reported illnesses or injuries. The potential impact on product effectiveness has not been confirmed—the source indicates that temperature exposure 'may have' affected the product, making this a precautionary recall.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Excelsior Heparin Sodium Porcine, Preservative Free 100 U/mL Solution Prefilled Syringes (Model 513604). This is an injectable anticoagulant product.
The recall was issued because the manufacturing facility experienced temperature excursions between June and August 2021 prior to product delivery. Exposure to elevated temperatures may have impacted the product's effectiveness.
This recall affects 13 boxes of product with lot numbers received between June 1, 2021, and September 30, 2021. The affected product was distributed nationwide in the United States.
The recalled product
- Product
- Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model Number: 513604
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- heat-damage
- efficacy-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 (3)
- GTIN: 00363807600515
- 10363807600055
- 00363807600058
Distribution
Distributed nationwide across the United States.
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