Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that requi
Summary
The FDA issued a Class II for Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use i by TELEFLEX LLC. Reason: Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that r.
Details
Source
Device Recall
External ID
Z-1663-2023
Action Date
2023-06-07
Status
Ongoing
Category
device
Product Description
Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
Lot/Code Info: UDI/DI 24026704696394, Lot Numbers: 73A2200857, 73A2300018, 73A2300176, 73A2300326, 73A2300520, 73A2300778, 73D2200216, 73D2200559, 73E2200634, 73E2200874, 73E2201099, 73F2200193, 73F2200200, 73F2200482, 73F2200711, 73G2200168, 73G2200345, 73G2200560, 73G2200754, 73H2200115, 73H2200294, 73H2200433, 73H2200453, 73J2200747, 73J2200763, 73K2200014, 73K2200095, 73K2200101, 73K2200299, 73K2200566, 73K2200713, 73L2200064, 73L2200066
Quantity Affected: 146,606 units
Reason for Recall
Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the cartridge, the clip is mounted in a more variable position, allowing the clips to load farther back in the clip applier jaw grooves. This may potentially result in inappropriate or inadequate clip application to vascular structures.
Distribution
worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-28
Company
Morrisville, NC
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 137 device recalls issued in the same week, part of 413 device-related FDA actions this month.
TELEFLEX LLC has 139 FDA actions in our database, including 139 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 (TELEFLEX LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TELEFLEX LLC have FDA actions?
TELEFLEX LLC has 139 FDA actions in our database, including 139 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1663-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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