Customed Cysto Tur Pack Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 176 units of Cysto Tur Pack Basic 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 medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 176 units of the Cysto Tur Pack Basic, a medical device used by staff for surgical and patient care procedures. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released as sterile.
The affected products were distributed only in Puerto Rico. The recall includes specific lots with expiration dates ranging from December 31, 2015, to June 30, 2016. The agency has classified this as a Class II recall.
Healthcare facilities and consumers should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- CYSTO TUR PACK BASIC 8/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
- Affected units
- 176
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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