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Terminated

STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

FDA Recall Z-2035-2020 · Posted None

Recalling FirmApplied Medical Resources Corp
Recall StatusTerminated
Product CodeDSS
Date Initiated2020-01-31
Date Terminated2022-04-20
Product Quantity2240 units

Reason for Recall

Failure of cardiovascular clips to provide sufficient occlusion of the vessel.

Firm Action

On 01/31/2020, Customer Notification Letter was sent to all consignees/ distributors requesting them to return the affected devices to the recalling firm.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K883909SURGICAL SPRING CLIPSApplied Vascular Devices, Inc. · 1988-12-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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