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Terminated

Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource PBDS Modules; Packaged by Cardinal Health Medical Products and services, McGaw Park, IL 60085 U.S.A.; There is no label on the Esmark bandage in the Presource pack/module, Some are placed in Tyvek pouches and some are just loose in the pack, but neither have any labeling on them. The Esmark bandage is used to support and compress a part of the patient's body. Presource Packs/Modules are manufactured, according to customer requirements, for use during surgical procedures.

FDA Recall Z-1667-2011 · Posted 2011-03-16

Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeLRO
Date Initiated2011-01-28
Date Terminated2012-09-04
Product Quantity4.395 modules

Reason for Recall

Esmark bandages placed in some Presource kits/modules may not have been adequately sterilized.

Firm Action

The firm, Cardinal Health, sent an "URGENT: PRODUCT RECALL" letter dated January 28, 2011 to all affected consignees/customers via UPS next day air. The letter described the product, problem and action to be taken. The customers were instructed to quarantine and return the packs/modules to Cardinal Health for destruction; contact the appropriate Customer Service group listed in the letter for return instructions, and complete and return the enclosed Acknowledgment Form via fax to 847-689-9101, regardless of whether or not they have inventory. Should you have any questions, relating to this recall, please feel free to contact Cardinal Health Quality Systems, 800-292-9332.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide distribution.

Official Source

View FDA Recall →

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

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