Customed Minor Procedure Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 80 Minor Procedure Packs 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 due to inadequate sterilization validation, and no injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 80 units of Minor Procedure Packs, catalog number 900052. These sterile medical supplies are used by medical staff to perform surgical procedures and patient care tasks, 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 the products released for distribution as sterile. The affected lots are 150116721 (exp. 1/31/16), 150317634 (exp. 3/31/16), 150418494 (exp. 4/30/16), and 150619101 (exp. 6/30/16).
The products were distributed only in Puerto Rico. The source text does not specify instructions for consumers or medical facilities regarding the return or disposal of these items.
The recalled product
- Product
- MINOR PROCEDURE PACK 40/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
- Affected units
- 80
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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