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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Syringe 60CC

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 Class 2 Device Recall McKesson Syringe 60CCsee related information
Date Initiated by FirmJuly 24, 2024
Date PostedAugust 29, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2940-2024
Recall Event ID 95041
510(K)NumberK103830 
Product Classification Syringe, piston - Product Code FMF
ProductMcKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
Code Information All lots of the affected product 102-S60C, SYRINGE, LL 60CC which are within their expiration date, are being recalled. Products were manufactured within the last five years. Affected lots: All lots beginning with alpha characters CLN. UDI-DI (01)30612479170316
Recalling Firm/
Manufacturer		 Cypress Medical Products LLC
9954 Mayland Dr
Richmond VA 23233-1464
For Additional Information ContactAlexia Allina
815-385-0100
Manufacturer Reason
for Recall		Affected syringes lack FDA clearance.
FDA Determined
Cause 2		Other
ActionOn July 24, 2024, the firm issued Urgent Medical Device Recall letters to affected customers. Consignees were advised that the affected syringes lack FDA clearance. Customers should immediately quarantine and discontinue use of any affected product. Recalled product should be destroyed on location. If you have further distributed the product, please notify your downstream accounts of the recall. For questions about this notification please contact productcomplaint@McKesson.com.
Quantity in Commerce24,693,200 eaches (US)
DistributionUS distribution only. Domestic distribution nationwide.
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.
510(K) Database510(K)s with Product Code = FMF
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