Customed Surgical Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 280 surgical packs 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 surgical packs) where the hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 280 units of Catalog Number 9002224 Surgical Packs. These products are used by medical staff to perform surgical procedures and patient care procedures such as 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 are SL15177, SL15191-01, SL15211, SL15229, and SL15258. These products were distributed only in Puerto Rico. The recall is classified as Class II by the U.S. Food and Drug Administration.
Medical facilities and consumers who have these specific surgical packs should stop using them and contact Customed, Inc. for further instructions or a return.
The recalled product
- Product
- Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 280
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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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