Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Recall
- Recall Number
- Z-1010-2026
- Event Number
- 98191
- Firm
- Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa
- FEI Number
- 2027111
- Product Code
- GCJ
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 11, 2025
- Posted
- January 2, 2026
- Address
- Margarita, CA, 92688-2650
Description
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
On December 11, 2025, Applied Medical issued a Urgent Medical Device Recall Notification to affected consignees via Email. Applied Medical ask consignees to take the following actions: 1. Check your inventory for recalled product. 2. Quarantine any product from the impacted lot. 3. Complete the attached Customer Recall Notification Confirmation Form. Please note that you must return the form even if you have no devices in inventory. 4. Please notify any facilities to which you distributed the affected product with a copy of this notification. Please also complete the Distributor Recall Notification Confirmation Report. 5. Return the Recall Notification Confirmation Form to Applied Medical by emailing to [email protected] 6. Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical
US: MI, CA, ME, OUS: France Great Britain, Germany
450 units