Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 507 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
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 507 units of Cesarean Packs (Code 900403) that were distributed exclusively in Puerto Rico. The recall was initiated because the company identified inadequate validation and qualification of the sterilization processes used for these products. Additionally, there were concerns regarding the package integrity of the items released for distribution as sterile.
The affected products are used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and wound irrigation. The recall covers specific lots with expiration dates ranging from October 31, 2015, to May 31, 2016. The specific lot numbers involved are 141015707, 141216329, 150116529, 150116530, 150116531, 150116532, 150317799, 150317800, 150317801, 150317802, 150418395, 150418394, 150418396, 150518580, and 150518581.
This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Medical facilities in Puerto Rico should stop using the affected lots and contact the recalling firm for further instructions.
The recalled product
- Product
- CESAREAN PACK 3/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
- 507
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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