McKesson 60 mL Syringes Recalled Lacking FDA Clearance
Cypress Medical Products is recalling McKesson 60 mL syringes that lack FDA clearance. The syringes were inadvertently shipped from a distribution center due to an order processing error and were on quarantine.
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, injuries, or identified safety defects. The issue is regulatory non-compliance due to an order processing error resulting in inadvertent distribution of uncleared medical devices, constituting a voluntary precautionary recall.
Plain-English summary
Cypress Medical Products LLC is recalling McKesson 60 mL General Purpose Syringes with Luer Lock Tip Without Safety (Catalog Number 869662, McKesson Brand Catalog Number 102-S60C). The FDA determined that these syringes lack the required FDA clearance for distribution.
The syringes were inadvertently shipped from a distribution center due to an internal order processing error. The product had been placed on quarantine when the regulatory status issue was identified.
The product was distributed nationwide in California, Nevada, and New York. Approximately 75 units are involved in this recall (3 boxes with 25 syringes per box).
Cyprus Medical Products and healthcare providers should stop distribution and contact affected customers. Any units that have been distributed should not be used.
The recalled product
- Product
- General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
- Manufacturer
- Cypress Medical Products LLC
- Category
- Medical Device — Syringes
- Hazard
- uncleared-medical-device
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 (1)
- UDI-DI: 20612479170302
Distribution
Distributed nationwide across the United States.
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