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Terminated

Synaptive Trackable Suction Set Standard and Malleable

FDA Recall Z-1955-2021 · Posted None

Recalling FirmSynaptive Medical Inc
Recall StatusTerminated
Product CodeGCX
Date Initiated2021-04-23
Date Terminated2024-01-12
Product Quantity1291 units

Reason for Recall

Due to visible burrs/metal filings affixed along the suction tube inner perimeter.

Firm Action

On April 23, 2021 the firm sent a letter to its consignees with the following instructions: 1. Quarantine and discontinue use of all Synaptive Trackable Suction devices. 2. Contact Synaptive Recall Support at 1.866.853.8001 or by email at [email protected]. Customer service will schedule an on-site inspection of each device. If this is not possible, arrangements will be made to have all impacted units returned to Synaptive. 3. Once on-site inspection or return of your stock has been arranged, please complete and return the attached Acknowledgement and Receipt Form. All forms should be submitted by email to [email protected]. Note: If you are in North America and your account is supported by a Synaptive Clinical Applications Specialist (CAS), then a company representative may have already visited your site and conducted the necessary inspections. If so, we kindly ask that you still complete the Acknowledgement and Receipt Form for our records. 4. Upon inspection, all units will be graded as pass or fail. Units that pass meet normal specifications and are safe for continued use. These devices will be returned and released back into circulation. Failing (i.e. defective) units will be removed immediately and replaced by Synaptive at no cost.

Root Cause

Vendor change control

Distribution Pattern

Domestic Distribution: IN, SC, MD, OR, TX ,LA, MI, NY, NV, FL, VA, CA,WI, PA and NC. International Distribution: Australia, Canada, Belgium, Netherlands, Singapore, Switzerland, Thailand, UK, Vietnam

Official Source

View FDA Recall →

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

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