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Terminated

Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.

FDA Recall Z-1233-2017 · Posted 2017-02-22

Recalling FirmDegania Silicone, Ltd.
Recall StatusTerminated
Product CodeGBX
Date Initiated2017-01-31
Date Terminated2017-04-04
Product Quantity3040 units

Reason for Recall

Product sterility compromised due to breach of sterile barrier

Firm Action

Degania Silicone Ltd. issued an Urgent Recall letter dated 1/31/17 and requested return of the product to Degania Silicone 14 Thurber Boulevard, Suite A, Smithfield, RI 02917, USA.. For questions regarding this recall call +1-401-349-5373.

Root Cause

Packaging process control

Distribution Pattern

To PR only

Official Source

View FDA Recall →

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

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