Recall Z-2034-2020
Applied Medical Resources Corp · initiated January 31, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Codes / lots: LOT # 1359929, Manufacture Date June 28, 2019; Expiration Date June 26, 2024
Reason for recall
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
FDA-determined cause: Nonconforming Material/Component
Action taken
On 01/31/2020, Customer Notification Letter was sent to all consignees/ distributors requesting them to return the affected devices to the recalling firm.
Details
- Recall number
- Z-2034-2020
- Initiated
- January 31, 2020
- Terminated
- April 20, 2022
- Product code
- DSS – Clip, Vascular
- Quantity
- 2240 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KY, MA, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA. WA and WI. The countries of Austria, Australia, Canada, Switzerland, Germany, Spain, Finland, France, Italy, Japan, Mexico, and Netherlands.
- Recalling firm
- Applied Medical Resources Corp, Rancho Santa Margarita, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2035-2020 Class II | STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product…Failure of cardiovascular clips to provide sufficient occlusion of the vessel. | 01/31/2020Terminated |
| Z-2036-2020 Class II | STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product…Failure of cardiovascular clips to provide sufficient occlusion of the vessel. | 01/31/2020Terminated |
| Z-2037-2020 Class II | STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile…Failure of cardiovascular clips to provide sufficient occlusion of the vessel. | 01/31/2020Terminated |