Customed Major Lap Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Major Lap 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 is classified as FDA Class II. The hazard involves a risk-of-harm product (sterile surgical packs) where the failure of sterilization validation poses a risk of infection, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 2,736 units of Major Lap Packs (Code 900404) that were distributed in Puerto Rico. These medical device packs 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 because of inadequate validation and qualification of the sterilization processes and package integrity for the products released for distribution as sterile. The affected lots have expiration dates ranging from October 31, 2015, to June 30, 2016.
Healthcare facilities and consumers who possess these specific lots should stop using the products and contact the recalling firm for further instructions.
The recalled product
- Product
- MAJOR LAP PACK 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 Packs
- Affected units
- 2,736
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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