Customed Endoveneous Custom Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 20 units of Endoveneous Custom Packs 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies this as an FDA Class II recall involving inadequate sterilization validation. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are classified as Severe (4). While no specific injuries are reported in the text, the failure of sterilization validation for surgical products poses a significant risk of infection, aligning with the 'Severe' criteria for significant injury potential or structural defects in medical devices.
Plain-English summary
Customed, Inc. is recalling 20 units of Endoveneous Custom Packs (Code 9001937) that were distributed only in Puerto Rico. 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 lots include 140714214 (exp. 11/30/15), 150116750 (exp. 1/31/16), 150317706 (exp. 5/31/16), and 150418329 (exp. 5/31/16). These products are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation.
The FDA has classified this recall as Class II. Consumers and medical facilities should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- ENDOVENOUS CUSTOM PACK 5/CS CUSTOMED 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
- 20
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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