Customed Laparoscopy Kits Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 244 laparoscopy kits 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. The hazard involves inadequate sterilization validation, which poses a risk of infection or harm, but the source text does not report any specific illnesses, injuries, or fatalities, placing it in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 244 units of the Laparoscopy PK 4/CS. These medical kits 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, as well as issues with package integrity for products released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The recall covers specific lots with expiration dates ranging from October 31, 2015, to June 30, 2016. The specific lot numbers and expiration dates are listed in the official recall documentation.
Medical facilities and consumers who have these products should stop using them and contact Customed, Inc. for instructions on how to return or dispose of the items. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- LAPAROSCOPY PK 4/CS 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
- 244
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 170 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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