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U.S. Department of Health and Human Services

Class 2 Device Recall General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety

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 Class 2 Device Recall General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safetysee related information
Date Initiated by FirmAugust 06, 2024
Date PostedSeptember 16, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3154-2024
Recall Event ID 95223
Product Classification Syringe, piston - Product Code FMF
ProductGeneral Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
Code Information UDI-DI: 20612479170302;
Recalling Firm/
Manufacturer		 Cypress Medical Products LLC
9954 Mayland Dr
Richmond VA 23233-1464
For Additional Information ContactRandy King
804-553-2068
Manufacturer Reason
for Recall		The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.
FDA Determined
Cause 2		Process control
ActionAn Urgent Product Recall Notification letter dated 8/6/24 was sent to customers. Actions to be Taken 1. Immediately quarantine and discontinue use of any product matching the affected items and lot numbers listed above. Affected items should be destroyed on location per appropriate local, state, and federal disposal requirements. 2. Please complete and return the enclosed response form (Attachment #1) as soon as possible, even if you do not have any product on hand or have already consumed the product. Return completed form to MMSQRCProductReviews@Mckesson.com. 3. If you have further distributed this product to end users, please notify them immediately of this urgent product recall and ask them to segregate and quarantine this product immediately. You are encouraged to include a copy of this notification letter in your communication with any of these end users. If you have questions regarding this notification, please contact McKesson directly by phone at (800) 688-8840 or email MMSQRCProductReviews@Mckesson.com. Representatives are available Monday Friday, 8:00 am 5:00 pm PST.
Quantity in Commerce3 Boxes (25 per box, 75 total units)
DistributionUS Nationwide distribution in the states of CA, NV, NY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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