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
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
Related recalls
Same manufacturer · Cypress Medical Products LLC
See all →- ModerateBinaxNOW Respiratory Strep A Test Kits Shipped to Unlicensed Purchasers
FDA (Devices) · 2024-09-25
- HighAcceava Respiratory Strep A test kits recalled for unlicensed distribution
FDA (Devices) · 2024-09-25
- ModerateMcKesson 60CC Sterile Syringes Recalled for Lack of FDA Clearance
FDA (Devices) · 2024-09-04
- HighMcKesson Lap Sponges Recalled for Failed Sterilization Indicator
FDA (Devices) · 2021-09-22
- LowMcKesson Consult Diagnostic Fecal Occult Blood Test Recalled for Packaging Issues
FDA (Devices) · 2019-04-10
Same hazard · uncleared medical device
See all →- HighBlood Glucose Meter Recalled for Marketing Without FDA Clearance
FDA (Devices) · 2022-08-03
- HighEvexia Luxe DVT Prevention Device Recalled for Marketing Without FDA Clearance
FDA (Devices) · 2021-08-25
- ModerateCell Marque Rabbit Monoclonal Antibody Distributed Without FDA Clearance
FDA (Devices) · 2021-07-28
- ModerateMedical device recall: Lingen SAMPLE Virus Sampling Kit lacks FDA clearance
FDA (Devices) · 2021-07-21
- HighUltrasonic Transducer Probe Cover Recall: Missing FDA 510(k) Clearance
FDA (Devices) · 2021-06-30