Customed Skin Staple Remover Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,180 Skin Staple Remover 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling 2,180 units of the Skin Staple Remover Kit 80/CS. These medical devices 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 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 specific lot numbers and expiration dates involved in the recall are 150116966 (exp. 1/31/16), 150317662 (exp. 3/31/16), and 150518842 (exp. 5/31/16). The source text does not report any illnesses or injuries associated with the use of these devices.
Healthcare facilities and consumers should stop using the affected Skin Staple Remover Kits and contact Customed, Inc. for further instructions on how to return or dispose of the products.
The recalled product
- Product
- SKIN STAPLE REMOVER KIT 80/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
- 2,180
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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