Customed Laparoscopy Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 60 units of Laparoscopy Surgical Packs 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 without reported injury.
Plain-English summary
Customed, Inc. is recalling 60 units of Catalog Number 900028 Laparoscopy Surgical Packs. 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 products were distributed only in Puerto Rico. The recall covers specific lots including SL15194, SL15195-02, and SL15258, with associated dates of July 31, 2016.
Consumers and healthcare facilities should stop using these products and contact the recalling firm for further instructions or a return.
The recalled product
- Product
- Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
- Manufacturer
- Customed, Inc
- Affected units
- 60
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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