McKesson 60CC Sterile Syringes Recalled for Lack of FDA Clearance
Cypress Medical Products is recalling approximately 24.7 million McKesson 60CC sterile syringes nationwide because they lack FDA clearance. All affected lots beginning with CLN within their expiration date are included.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory non-compliance (lack of FDA clearance) rather than an identified product defect or safety threat.
Plain-English summary
Cypress Medical Products LLC is recalling McKesson Syringe 60CC, Luer Lock Tip, Sterile (Model 102-S60C) because the syringes lack FDA clearance. Approximately 24.7 million units are subject to recall, distributed nationwide in the United States.
All lots of the affected product beginning with the letters CLN that are within their expiration date are included. These syringes were manufactured within the last five years. The product identifier is Model 102-S60C with UDI-DI (01)30612479170316.
For more information about this recall, contact Cypress Medical Products LLC.
The recalled product
- Product
- McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
- Manufacturer
- Cypress Medical Products LLC
- Category
- Medical Device — Syringe
- Affected units
- 24,693,200
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)
- All lots of the affected product 102-S60C
- SYRINGE
- LL 60CC which are within their expiration date
Distribution
Distributed nationwide across the United States.
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