Customed Extremity Arm Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 148 Extremity Arm Packs distributed in Puerto Rico 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, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 148 units of the Extremity Arm Pack (Code 9002438). These medical device packs 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 products were distributed only in Puerto Rico. The recall includes specific lots with expiration dates ranging from November 30, 2015, to May 31, 2016. The source text does not report any illnesses or injuries associated with these products.
Healthcare facilities and consumers who have these specific products should stop using them and contact Customed, Inc. for further instructions on return or disposal.
The recalled product
- Product
- EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER 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 Packs
- Affected units
- 148
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.
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