Customed Lumbar Packs Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 12 Lumbar Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the failure of sterilization validation creates a potential for infection, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Customed, Inc. is recalling 12 units of Lumbar Packs (Code 9002284) that were distributed only in Puerto Rico. The affected lots are 150116627, 150116628, and 150116629, all with an expiration date of 1/31/16. These medical packs are used by staff to perform surgical and patient care procedures, including wound healing and suture removals.
The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for products released for distribution as sterile. This means the manufacturer could not verify that the sterilization method was effective or that the packaging remained intact to maintain sterility.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items, nor does it report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- LUMBAR 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
- 12
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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