The Recall Desk
HighFDA (Devices)·Z-2649-2015·Announced 2015-09-09

Customed Open Heart Packs Recalled for Sterilization Validation Issues

Customed, Inc. is recalling 27 Open Heart Packs due to inadequate validation of sterilization processes and package integrity.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where the hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses have been reported.

Plain-English summary

Customed, Inc. is recalling 27 units of Open Heart Packs. These medical supplies are used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and wound irrigation.

The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots were distributed only in Puerto Rico.

Healthcare facilities and consumers should stop using the affected Open Heart Packs and contact the manufacturer or their supplier for further instructions.

The recalled product

Product
OPEN HEART PACK 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Manufacturer
Customed, Inc
Category
Medical Device — Surgical Supplies
Hazard
Affected units
27

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 170 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 170 products in this recall →

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