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Terminated

Catalog Number: 9001933 OPHTALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA Recall Z-1439-2016 · Posted 2016-04-14

Recalling FirmCustomed, Inc
Recall StatusTerminated
Product CodeOJK
Date Initiated2016-01-07
Date Terminated2017-05-03
Product Quantity168

Reason for Recall

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Firm Action

Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.

Root Cause

Packaging

Distribution Pattern

Distributed only in Puerto Rico.

Official Source

View FDA Recall →

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

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