Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Summary
The FDA issued a Class II for Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23 by Applied Medical Resources Corp. Reason: There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing..
Details
Source
Device Recall
External ID
Z-1010-2026
Action Date
2026-01-14
Status
Ongoing
Category
device
Product Description
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Lot/Code Info: UDI: (01)00607915126582; Lot # 1546141
Quantity Affected: 450 units
Reason for Recall
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Distribution
US: MI, CA, ME, OUS: France Great Britain, Germany
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-11
Company
Rancho Santa Margarita, CA
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 98 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Applied Medical Resources Corp has 6 FDA actions in our database, including 3 recalls and 3 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 (Applied Medical Resources Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Applied Medical Resources Corp have FDA actions?
Applied Medical Resources Corp has 6 FDA actions in our database, including 3 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1010-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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