Customed Premium Laparotomy Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 258 Premium Laparotomy 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.
Plain-English summary
Customed, Inc. is recalling 258 units of the Premium Laparotomy Pack (Catalog Number 9001296). 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 the sterilization processes and package integrity for products that were released for distribution as sterile. The affected lots were distributed only in Puerto Rico.
No specific instructions for consumers are provided in the source text, but the recall is limited to the specific lot numbers and dates listed in the agency record.
The recalled product
- Product
- Catalog Number: 9001296 PREMIUM LAPAROTOMY 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
- 258
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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