Customed Cysto TUR Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 290 packs of Cysto TUR Pack 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 recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a medical device with potential for serious injury (due to sterilization failure) is rated as Severe.
Plain-English summary
Customed, Inc. is recalling 290 packs of the Cysto TUR Pack Customed 10/CS Rev. C 10/13 Non Sterile. This medical device is 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 that were released for distribution as sterile. The affected lots are 141015782 (exp. 8/30/19), 141216312 (exp. 12/31/15), and 150116979 (exp. 1/31/16). The products were distributed only in Puerto Rico.
Healthcare facilities and consumers in Puerto Rico should stop using these specific packs and contact Customed, Inc. for further instructions or a return.
The recalled product
- Product
- CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE 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
- 290
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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