Customed Liver and Pancreas Surgery Kits Recalled for Sterilization Issues
Customed, Inc. is recalling 20 liver and pancreas surgery kits 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 medical device with a risk of harm due to potential lack of sterility, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 20 units of Catalog Number 9001966 Liver & Pancreas Surgery kits. These products 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 that were released for distribution as sterile. The affected lots are SL15195-01, SL15210, SL15211, SL15223, SL15224, and SL15275, with distribution dates ranging from July 31, 2016, to September 30, 2016.
The products were distributed only in Puerto Rico. Medical facilities and consumers should stop using these specific kits and contact the recalling firm for further instructions.
The recalled product
- Product
- Catalog Number: 9001966 LIVER & PANCREAS SURGERY 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 Kits
- Affected units
- 20
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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