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Terminated

ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Personal Lubricant.

FDA Recall Z-1904-2009 · Posted 2009-08-27

Recalling FirmMemphis Fertility Laboratory Inc
Recall StatusTerminated
Product CodeNUC
Date Initiated2009-07-10
Date Terminated2009-10-05
Product Quantity800 units

Reason for Recall

Product was marketed without a 510(k).

Firm Action

The firm notified its sole consignee on 07/10/2009 by telephone and followed by an Urgent Medical Device Recall letter. The letter requested that they examine their inventory and quarantine all products subject to recall and immediately contact Dr. William Kutteh for return instructions. The enclosed response form should be completed and returned. Questions should be directed to Dr. Kutteh at 901-261-2401.

Root Cause

PMA

Distribution Pattern

Nationwide Distribution -- USA, including the state of MA.

Official Source

View FDA Recall →

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

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