Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47
Summary
The FDA issued a Class II for Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. by Medline Industries, LP. Reason: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601..
Details
Source
Device Recall
External ID
Z-2595-2026
Action Date
2026-07-01
Status
Ongoing
Category
device
Product Description
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
Lot/Code Info: DYNJ47717A UDI-DI 10193489454529 Lots 21CMD153 21EMC033 21HMB521 21HMF278 21IME100 21IMG896 21JMG286 22AME235 22BMH056 22EMF125 22GMI215 22JME782 22LMC139 22LMC336
Quantity Affected: 113, 843 kits
Reason for Recall
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Distribution
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-27
Company
Northfield, IL
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 252 device recalls issued in the same week, part of 389 device-related FDA actions this month.
Medline Industries, LP has 465 FDA actions in our database, including 435 recalls and 30 clearances.
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 (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 465 FDA actions in our database, including 435 recalls and 30 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2595-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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