Customed NEURO PACK Surgical Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 64 NEURO PACK surgical kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
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 exposure to non-sterile medical devices, which poses a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 64 units of NEURO PACK surgical kits. These products 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 products released for distribution as sterile.
The affected lots were distributed only in Puerto Rico. The specific lot numbers and expiration dates are 141015762 (exp. 11/30/15), 141216323 (exp. 12/31/15), 150116792 (exp. 3/31/16), 150518691 (exp. 5/31/16), and 150317817 (exp. 5/31/16). The product code is 9002256.
Medical 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
- NEURO PACK 2/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 Kits
- Affected units
- 64
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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