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Terminated

PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.

FDA Recall Z-0732-2016 · Posted 2016-01-30

Recalling FirmJosNoe Medical, Inc.
Recall StatusTerminated
Product CodeNWV
Date Initiated2015-12-01
Date Terminated2016-03-22
Product Quantity1008 boxes

Reason for Recall

Damage to package seals potentially compromising sterility.

Firm Action

On 12/1/2015, notifications were sent to the affected customers via e-mail. The recall notification included a description of the reason for the recall, the affected product, and instructions for identifying and returning the affected product.

Root Cause

Packaging process control

Distribution Pattern

Distributed US (nationwide) and in Canada.

Official Source

View FDA Recall →

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

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