Customed Laparoscopy-Colorectal Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 84 laparoscopy-colorectal surgical packs 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 source text does not report any illnesses or injuries, and the hazard is theoretical (inadequate sterilization validation), which aligns with the rubric criterion for a score of 3 (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Customed, Inc. is recalling 84 units of Catalog Number 9002259A Laparoscopy-Colorectal Surgical Packs. These products 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 package integrity issues 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 May 2016 to September 2016, including lot numbers SL15173, SL15195-01, SL15199, SL15208, SL15212, SL15224, SL15243, and SL15260. The source text does not report any illnesses or injuries associated with the use of these products.
Healthcare facilities and consumers should stop using these products and contact the recalling firm for instructions on return or disposal. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK 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
- 84
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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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