Customed Orthopedic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 90 units of Orthopedic Pack Basic surgical packs distributed in Puerto Rico due to inadequate sterilization process validation and package integrity concerns.
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 potential sterility failure in surgical packs, which poses a risk of infection (risk-of-harm), but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 90 units of Orthopedic Pack Basic surgical packs. These products are used by medical staff for surgical procedures and patient care, 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 products released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The recall involves specific lot numbers 141015715, 140915331, and 141216445, with expiration dates of October 31, 2015, and December 31, 2015. The product code is 9002830.
Medical facilities and consumers who have these specific lots should stop using the products and contact Customed, Inc. for further instructions or a return. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ORTHOPEDIC PACK BASIC 5/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
- 90
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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