Customed Cysto Tur Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 50 units of Cysto Tur Pack 5/CS 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 and involves a risk-of-harm product (sterile medical device) where the hazard is theoretical due to inadequate sterilization validation, with no reported injuries or illnesses in the source text.
Plain-English summary
Customed, Inc. is recalling 50 units of Cysto Tur Pack 5/CS. These medical packs are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation. 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 products were distributed only in Puerto Rico. The specific lots involved are 141015764 (exp. 10/31/15), 150116563 (exp. 12/31/15), and 150518803 (exp. 5/31/16). The agency classification for this recall is Class II.
Healthcare facilities and consumers should stop using these specific lots of the Cysto Tur Pack 5/CS and contact the recalling firm for further instructions or a return.
The recalled product
- Product
- CYSTO TUR PACK 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
- 50
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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