McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
Summary
The FDA issued a Class II for McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102 by Cypress Medical Products LLC. Reason: Affected syringes lack FDA clearance..
Details
Source
Device Recall
External ID
Z-2940-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
Lot/Code Info: 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
Quantity Affected: 24,693,200 eaches (US)
Reason for Recall
Affected syringes lack FDA clearance.
Distribution
US distribution only. Domestic distribution nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-24
Company
Richmond, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 409 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cypress Medical Products LLC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cypress Medical Products LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cypress Medical Products LLC have FDA actions?
Cypress Medical Products LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2940-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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