Customed Basic Surgical Packs Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 152 Basic Surgical 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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (sterile surgical packs) where the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling 152 units of the Basic Surgical Pack (Catalog Number 9002829). These sterile 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 the sterilization processes and package integrity for the products released for distribution as sterile. The affected lots are SL15187, SL15191-01, SL15244, SL15264, SL15273, and SL15274, with manufacturing dates ranging from July 31, 2016, to September 30, 2016.
The affected products were distributed only in Puerto Rico. The source text does not specify the exact actions consumers or medical facilities should take, such as whether to stop use or return the products to the manufacturer.
The recalled product
- Product
- Catalog Number: 9002829 BASIC SURG 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
- Category
- Medical Device — Surgical Packs
- Affected units
- 152
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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