Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.
FDA Recall Z-1131-2018 · Posted None
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Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeKNG
Date Initiated2017-10-06
Date Terminated2020-02-06
Product Quantity13 units
Reason for Recall
The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe
Firm Action
CooperSurgical sent an Urgent Medical Device Recall letter dated October 6, 2017 to affected customers via UPS with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to discontinue use of affected products and complete the attached Acknowledgement and Receipt Form for replacement. If you have any further questions please feel free to contact me at 203.601.5200.
Root Cause
Error in labeling
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of ( Canada and England)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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