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Terminated

Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345

FDA Recall Z-0401-2019 · Posted None

Recalling FirmSafe N Simple, LLC
Recall StatusTerminated
Product CodeNAE
Date Initiated2018-08-22
Date Terminated2020-03-17
Product Quantity125 cases

Reason for Recall

The sterilization process used was unqualified.

Firm Action

Safe n Simple extended the recall to the only customer that ordered the product in the lot numbers (see table). The firm provided a written notice to the customer mentioned in the table with specific instructions along with a phone conversation. Safe n Simple instructed the customer to provide the inventory level of SNS58315 and SNS58345 specific to lot numbers 18060564 and 18060563 respectively and to return such product to Safe N Simple LLC at Safe N Simple LLC expense. The effectiveness of the recall was good since the customer immediately responded by shipping all their inventory back to us.

Root Cause

Process control

Distribution Pattern

CA

Official Source

View FDA Recall →

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

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