Customed Recalls Sterile Surgical Kits Due to Sterilization Validation Issues
Customed, Inc. is recalling 248 units of sterile surgical kits in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk-of-harm product (sterile surgical kits) where the hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses have been reported.
Plain-English summary
Customed, Inc. is recalling 248 units of HIGADO Y PANCREA 2/CS sterile surgical kits. These products are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation. The recall was initiated due to inadequate validation and qualification of sterilization processes and package integrity for products released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The recall includes specific lots with expiration dates ranging from October 2015 to April 2016. The agency has classified this recall as Class II.
Healthcare facilities and consumers who have these products should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- HIGADO Y PANCREA 2/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
- 248
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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