Customed Premium Cesarean Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 25 Premium Cesarean 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 is classified as FDA Class II and involves a risk-of-harm product (sterile surgical packs) where the hazard is theoretical due to inadequate sterilization validation, with no reported illnesses or injuries in the source text.
Plain-English summary
Customed, Inc. is recalling 25 Premium Cesarean Packs (Code 9001294) that were distributed in Puerto Rico. The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for these products, which were released for distribution as sterile.
The affected lots include 141015769, 141115974, 150116729, 150217261, 150318132, and 150418450, with expiration dates ranging from November 30, 2015, to April 30, 2016. These packs are used by medical staff for surgical procedures and patient care, such as wound healing and suture removals.
Medical facilities and staff in Puerto Rico should stop using these specific lots immediately and contact Customed, Inc. for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- PREMIUM CESAREAN PACK CUSTOMED 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
- 25
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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